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Class II: temporary or reversible health riskOngoing

Apipharma Kapsin Ointment Recall

Kapsin Ointment, Camphor 3

Apipharma · Zagreb, N/A

Risk level
Class II
Reported by FDA
Apr 30, 2025
Recall ID
D-0376-2025
Check your lot numberHow we source this data

Summary

Apipharma recalled Kapsin Ointment starting Apr 9, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0376-2025 on Apr 30, 2025. Reason: CGMP Deviations. Status: Ongoing.

Why it was recalled

CGMP Deviations

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 153211, Exp.: 2025-04; 210221, Exp.: 2026-05.

Where it was sold

AZ

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0376-2025
Classification
Class II
Status
Ongoing
Recall initiated
Apr 9, 2025
FDA report date
Apr 30, 2025
Quantity
5,095 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Apipharma

Original FDA data

Every field from FDA enforcement report D-0376-2025, exactly as published.

Show all FDA fields
City
Zagreb
Status
Ongoing
Country
Croatia
Event ID
96601
Address
Ulica Jeronima Kavanjina 26
Code information
Lot #: 153211, Exp.: 2025-04; 210221, Exp.: 2026-05.
Report date
Apr 30, 2025
Product type
Drugs
Recall number
D-0376-2025
Classification
Class II
Recalling firm
Apipharma
Product quantity
5,095 cartons
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
AZ
Recall initiation date
Apr 9, 2025
Initial firm notification
Letter
Center classification date
Apr 18, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0376-2025, published Apr 30, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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