CLASS II ONGOING Drug recall · Reported 30 Apr 2025 · FDA Enforcement Report
Kapsin Ointment, Camphor 3.16% and Capsaicin recalled by Apipharma
Apipharma is recalling Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%, distributed in Arizona. The recall was initiated on 9 Apr 2025 and the FDA has classified it as Class II.
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-0376-2025
- FDA event ID
- 96601
- Recalling firm
- Apipharma, Zagreb, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Apr 2025
- FDA classified
- 18 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 9 Apr 2025 | Recall initiated by company | |
| 18 Apr 2025 | Classified by FDA | +9 days |
| 30 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363
Where it was distributed
AZ
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #: 153211, Exp.: 2025-04; 210221, Exp.: 2026-05.
Where was it sold?
AZ
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
1 other product · FDA event 96601This product is part of a recall event; the main page for the event is Hemopropin Ointment, Lanolin 17.76% and Petrolatum recalled by Apipharma.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hemopropin Ointment, Lanolin 17.76% and Petrolatum recalled by Apipharma | Apipharma | Manufacturing (CGMP) Deviations | AZ |
More recalls from Apipharma
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hemopropin Ointment, Lanolin 17.76% and Petrolatum recalled by Apipharma | Apipharma | Manufacturing (CGMP) Deviations | AZ |