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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95714

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

Open FDA event record

Event summary

Timeline bucket
November 04, 2024
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Boulla 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

4 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 4

VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com

D-0083-2025
Recall number
D-0083-2025
Initiated
November 04, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Boulla LLC
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Code information

Lot #: 230811, Exp: 08/11/2025

Distribution pattern

Nationwide within the United States

drug · product 2 of 4

PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com

D-0084-2025
Recall number
D-0084-2025
Initiated
November 04, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Boulla LLC
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Code information

Lot #: 230811, Exp: 08/11/2025

Distribution pattern

Nationwide within the United States

drug · product 3 of 4

ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com

D-0085-2025
Recall number
D-0085-2025
Initiated
November 04, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Boulla LLC
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Code information

Lot #: YZM240406, Exp: 04/05/2027

Distribution pattern

Nationwide within the United States

drug · product 4 of 4

ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com

D-0086-2025
Recall number
D-0086-2025
Initiated
November 04, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Boulla LLC
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.

Code information

Lot #: YZM240406, Exp: 04/05/2027

Distribution pattern

Nationwide within the United States