Topical ointment recalled for manufacturing practice deviations
Apipharma is voluntarily recalling Kapsin Ointment due to manufacturing practice deviations identified at its Zagreb facility. The recall affects 5,095 cartons distributed in Arizona.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary, firm-initiated Class II recall due to manufacturing practice deviations. No specific hazard, illnesses, or injuries have been identified, characterizing this as a precautionary recall.
Plain-English summary
Kapsin Ointment is a topical pain relief product formulated with camphor 3.16% and capsaicin 0.03%, packaged in 2-ounce (60-gram) tubes. The product is manufactured by Apipharma d.o.o in Zagreb, Croatia and distributed in the United States by Apipharma, LLC in Tempe, Arizona. Approximately 5,095 cartons of the product were distributed in Arizona.
Apipharma initiated a voluntary recall on April 9, 2025 due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. CGMP deviations indicate that the facility did not maintain the manufacturing standards required by federal drug regulations. The FDA classified the recall as Class II.
The affected product carries lot numbers 153211 (expiration April 2025) and 210221 (expiration May 2026). Consumers who have purchased this product should verify the lot number and expiration date to determine if their product is included in this recall.
The recalled product
- 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
- Manufacturer
- Apipharma
- Category
- Drug — Topical Ointment
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 153211
- Exp.: 2025-04
- 210221
- Exp.: 2026-05.
Distribution
Distributed in 1 state:
- AZ
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