ANI Pharmaceuticals, Inc. recalls Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, I…

Recall date

May 12, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0543-2026

FDA classification

Class II

Brand / firm

ANI Pharmaceuticals, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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