FDA Recall D-0376-2025
Apipharma · Zagreb, N/A
Class II Ongoing 400 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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
Reason for recall
CGMP Deviations
Recall record
- Recall number
D-0376-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- AZ
- Recall initiated
- 2025-04-09
- Classified by FDA Center
- 2025-04-18
- FDA published
- 2025-04-30
- Recalling firm
- Apipharma
- Firm location
- Zagreb, N/A, Croatia
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.