FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled May 27, 2026

Estradiol Gel recall — ANI Pharmaceuticals, Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0543-2026
Brand
ANI Pharmaceuticals
Classification
Class II
Units affected
3964 Cartons
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

Affected products

Companies & origin

Recalling firm location
Baudette, MN, United States
Firm address
210 W Main St, 56623-2467

Identifying details (verbatim from the notice)

Product codes / lots
Lot M251109, exp Nov 2027
Distribution
Nationwide in the USA
Firm notified the public via
Letter
FDA event ID
98947
Recall initiated
May 12, 2026
FDA classified
May 20, 2026
FDA report date
May 27, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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