Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0375-2025·Announced 2025-04-30

Hemopropin Ointment Recalled Due to Manufacturing Process Deviations

Apipharma is voluntarily recalling Hemopropin Ointment due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects specific lot numbers distributed in Arizona.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: The recall is classified as FDA Class II and is based on CGMP deviations with no reported illnesses or injuries stated in the source. CGMP violations represent a manufacturing process defect that warrants caution but do not constitute a high-risk pathogen or imminent serious health hazard.

Plain-English summary

Apipharma, LLC is voluntarily recalling Hemopropin Ointment (Lanolin 17.76% and Petrolatum 71.2%, Net Weight 0.7 oz / 20g tubes) due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was manufactured by Apipharma d.o.o in Croatia and distributed by Apipharma, LLC in Tempe, Arizona.

The recall involves 4,218 boxes. The affected lot numbers are: A00001 (Expiration 2027-12), A00005 (Expiration 2027-01), and B00001 (Expiration 2028-02). The product is identified by UPCs 3 858882 103534 and 3 858882 101318.

Consumers who have purchased this product should stop using it. Consult a healthcare provider or pharmacist if you have questions about whether you have an affected product or if you have used it and have concerns about your health.

The recalled product

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
Manufacturer: Apipharma
Category: Drug — Topical / Ointment
Hazard: cgmp-deviation
manufacturing-defect
Affected units: 4,218

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 (6)

Lot #: A00001
Exp.: 2027-12
A00005
Exp.: 2027-01
B00001
Exp.:2028-02

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Apipharma under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Apipharma

See all →

Moderate
Kapsin Ointment Drug Recalled Due to Manufacturing Process Deviations
FDA (Drugs) · 2025-04-30

Same hazard · cgmp deviation