CLASS I ONGOING Drug recall · Reported 11 Dec 2024 · FDA Enforcement Report
PeakMax Capsules, 500 mg recalled by Boulla
Boulla is recalling PeakMax Capsules, 500 mg, distributed nationwide in the US. The recall was initiated on 4 Nov 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0084-2025
- FDA event ID
- 95714
- Recalling firm
- Boulla, Sacramento, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 4 Nov 2024
- FDA classified
- 2 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
Timeline
| 4 Nov 2024 | Recall initiated by company | |
| 2 Dec 2024 | Classified by FDA | +28 days |
| 11 Dec 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Product as listed by the FDA
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Which lots are affected?
Lot #: 230811, Exp: 08/11/2025
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95714This product is part of a recall event; the main page for the event is ZapMax Capsules, 500 mg blisters recalled by Boulla.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | ZapMax Capsules, 500 mg blisters recalled by Boulla | Boulla | Labeling Errors | Nationwide | |
| CLASS I | VitalityXtra Capsules, 500 mg recalled by Boulla | Boulla | Labeling Errors | Nationwide | |
| CLASS I | ZoomMax Capsules, 500 mg blisters recalled by Boulla | Boulla | Labeling Errors | Nationwide |
More recalls from Boulla
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | ZoomMax Capsules, 500 mg blisters recalled by Boulla | Boulla | Labeling Errors | Nationwide |
| Drug | CLASS I | VitalityXtra Capsules, 500 mg recalled by Boulla | Boulla | Labeling Errors | Nationwide |
| Drug | CLASS I | ZapMax Capsules, 500 mg blisters recalled by Boulla | Boulla | Labeling Errors | Nationwide |