Class II

Drug Recall: 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

ANI Pharmaceuticals, Inc. · May 12, 2026

Reason for Recall

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

3964 Cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0543-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.