Kapsin Ointment recalled over manufacturing violations

Recall date

April 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Apipharma recalls Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronim…

Recall number

D-0376-2025

FDA classification

Class II

Brand / firm

Apipharma

Sold / distributed

AZ

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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