FDA Recall D-0375-2025

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

Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318

Lot / code: Lot #: A00001, Exp.: 2027-12; A00005, Exp.: 2027-01; B00001, Exp.:2028-02

Quantity: 4,218 boxes

Reason for recall

CGMP Deviations

Recall record

Recall number: D-0375-2025
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.

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