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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97369

57 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 30, 2025
Product types
Drug
Classifications
Class I and Class II
Statuses
Ongoing
Recalling firm wording
GenoGenix LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

57 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 57

Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0038-2026
Recall number
D-0038-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
17

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 2 of 57

Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

D-0039-2026
Recall number
D-0039-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
235

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 3 of 57

Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0040-2026
Recall number
D-0040-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
30

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 4 of 57

Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0041-2026
Recall number
D-0041-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
1550

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 5 of 57

B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0042-2026
Recall number
D-0042-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
25

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 6 of 57

B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.

D-0043-2026
Recall number
D-0043-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 7 of 57

B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0044-2026
Recall number
D-0044-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
35

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 8 of 57

B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness

D-0045-2026
Recall number
D-0045-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 9 of 57

Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute

D-0046-2026
Recall number
D-0046-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 10 of 57

B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness.

D-0047-2026
Recall number
D-0047-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 11 of 57

Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0048-2026
Recall number
D-0048-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
296

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 12 of 57

Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0049-2026
Recall number
D-0049-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
184

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 13 of 57

GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0050-2026
Recall number
D-0050-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
3

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 14 of 57

GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0051-2026
Recall number
D-0051-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
221

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 15 of 57

Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health.

D-0052-2026
Recall number
D-0052-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 16 of 57

Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

D-0053-2026
Recall number
D-0053-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
907

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 17 of 57

Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

D-0054-2026
Recall number
D-0054-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
32

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 18 of 57

L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

D-0055-2026
Recall number
D-0055-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
53

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 19 of 57

L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0056-2026
Recall number
D-0056-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
83

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 20 of 57

L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

D-0057-2026
Recall number
D-0057-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
161

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 21 of 57

L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0058-2026
Recall number
D-0058-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
15

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 22 of 57

Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0059-2026
Recall number
D-0059-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
172

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 23 of 57

Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0060-2026
Recall number
D-0060-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
478

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 24 of 57

Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0061-2026
Recall number
D-0061-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
45

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 25 of 57

Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0062-2026
Recall number
D-0062-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
430

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 26 of 57

Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0063-2026
Recall number
D-0063-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
30

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 27 of 57

N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0064-2026
Recall number
D-0064-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
85

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 28 of 57

NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health

D-0065-2026
Recall number
D-0065-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 29 of 57

Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0066-2026
Recall number
D-0066-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
294

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 30 of 57

Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0067-2026
Recall number
D-0067-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
166

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 31 of 57

Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0068-2026
Recall number
D-0068-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
12

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 32 of 57

Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0069-2026
Recall number
D-0069-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
339

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 33 of 57

Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0070-2026
Recall number
D-0070-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
467

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 34 of 57

Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0071-2026
Recall number
D-0071-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 35 of 57

CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0072-2026
Recall number
D-0072-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 36 of 57

EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0073-2026
Recall number
D-0073-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 37 of 57

Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billion per vial, 8mL of solution in 10mL vial.

D-0074-2026
Recall number
D-0074-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 38 of 57

Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Medical Health Institute (MHI).

D-0075-2026
Recall number
D-0075-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 39 of 57

Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA Health.

D-0076-2026
Recall number
D-0076-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 40 of 57

Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0077-2026
Recall number
D-0077-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 41 of 57

Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0078-2026
Recall number
D-0078-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 42 of 57

Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0079-2026
Recall number
D-0079-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 43 of 57

pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 10mL.

D-0080-2026
Recall number
D-0080-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 44 of 57

Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.

D-0081-2026
Recall number
D-0081-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 45 of 57

Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0082-2026
Recall number
D-0082-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 46 of 57

Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0083-2026
Recall number
D-0083-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 47 of 57

Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0084-2026
Recall number
D-0084-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

All lots within expiry.

Distribution pattern

US Nationwide.

drug · product 48 of 57

BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.

D-0085-2026
Recall number
D-0085-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot#: GG012825-002 within expiry.

Distribution pattern

US Nationwide.

drug · product 49 of 57

BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI).

D-0086-2026
Recall number
D-0086-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot#: GG020525-001, GG060525-001, GG062625-004, within expiry.

Distribution pattern

US Nationwide.

drug · product 50 of 57

Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0087-2026
Recall number
D-0087-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot#: GG060525-001 within expiry.

Distribution pattern

US Nationwide.

drug · product 51 of 57

Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0088-2026
Recall number
D-0088-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot#: GG020425-004 within expiry.

Distribution pattern

US Nationwide.

drug · product 52 of 57

Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.

D-0089-2026
Recall number
D-0089-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot#: GG053025-002 within expiry

Distribution pattern

US Nationwide.

drug · product 53 of 57

Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0090-2026
Recall number
D-0090-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot#: GG062425-002 within expiry.

Distribution pattern

US Nationwide.

drug · product 54 of 57

Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.

D-0091-2026
Recall number
D-0091-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot#: GG021125-001, GG031125-017, within expiry.

Distribution pattern

US Nationwide.

drug · product 55 of 57

Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.

D-0092-2026
Recall number
D-0092-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lots GG012925-005, GG021125-003, within expiry.

Distribution pattern

US Nationwide.

drug · product 56 of 57

Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

D-0093-2026
Recall number
D-0093-2026
Initiated
July 30, 2025
Classification
Class II
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

Lot#: GG021125-019, within expiry.

Distribution pattern

US Nationwide.

drug · product 57 of 57

NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

D-0094-2026
Recall number
D-0094-2026
Initiated
July 30, 2025
Classification
Class I
Status
Ongoing
Recalling firm
GenoGenix LLC
Quantity
Unavailable

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Sterile Products: elevated endotoxin levels

Code information

Lot#: GG121624-023, within expiry

Distribution pattern

US Nationwide.