FDA Drugs recall ·
Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt recall
- Recall number
- D-0376-2025
- Date
- (initiated April 9, 2025)
- Company / brand
- Apipharma
Ulica Jeronima Kavanjina 26, Zagreb, N/A, Croatia - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5,095 cartons
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
CGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 153211, Exp.: 2025-04; 210221, Exp.: 2026-05.
Distribution
AZ
States: Arizona
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0376-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.