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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96308

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

Open FDA event record

Event summary

Timeline bucket
February 17, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Safecor Health, 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

5 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 5

Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.

D-0250-2025
Recall number
D-0250-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Safecor Health, LLC
Quantity
3069 Oral Syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Code information

Lot #: 24300812, Exp 01/31/2025; 24530836, Exp 07/19/2025

Distribution pattern

Nationwide in the USA

drug · product 2 of 5

Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.

D-0251-2025
Recall number
D-0251-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Safecor Health, LLC
Quantity
10992 Oral Syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Code information

Lot #s: 24201295, Exp 02/05/2025; 24210364, Exp 02/20/2025; 24231720, Exp 02/27/2025; 24500770, Exp 06/26/2025; 24471182, Exp 06/20/2025; 25031031, Exp 07/22/2025.

Distribution pattern

Nationwide in the USA

drug · product 3 of 5

Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.

D-0252-2025
Recall number
D-0252-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Safecor Health, LLC
Quantity
1535 Oral Syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Code information

Lot #s: a) 24250093, Exp 03/07/2025; 24321592, Exp 04/04/2025; 24280320, Exp 03/27/2025; b) 24371268, Exp 04/19/2025; c) 24400519, Exp 04/07/2025; 24500768, Exp 06/24/2025; 25040972, Exp 07/25/2025.

Distribution pattern

Nationwide in the USA

drug · product 4 of 5

Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784.

D-0253-2025
Recall number
D-0253-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Safecor Health, LLC
Quantity
3465 Oral Syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Code information

Lot #s: a) 24210274, Exp 01/31/2025; 24401700, Exp 04/25/2025; b) 24251067, Exp 03/25/2025; 24421733, Exp 06/03/2025; c) 24261384, Exp 03/24/2025; 24370127, Exp 04/28/2025.

Distribution pattern

Nationwide in the USA

drug · product 5 of 5

Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.

D-0254-2025
Recall number
D-0254-2025
Initiated
February 17, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Safecor Health, LLC
Quantity
12390 Oral Syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Code information

Lot #s: a) 24220672, Exp 02/19/2025; 24280145, Exp 03/18/2025; 24240711, Exp 03/19/2025; b) 24180729, Exp 01/23/2025; 25030427, Exp 07/17/2025; c) 24360865, 24360864, Exp 03/31/2025; 24480235, Exp 06/21/2025.

Distribution pattern

Nationwide in the USA