Recall: D-0543-2026

Class II - Potentially Harmful

Class IIClassification

2026-05-12Initiated

OngoingStatus

ANI Pharmaceuticals, Inc.Firm

Product

Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20

Reason

Defective Container; packets were found to be either empty or partially full.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.