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

Recall Number: D-0543-2026

Firm: ANI Pharmaceuticals, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260527

Initiation Date: 20260512

Termination Date:

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

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