⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

ANI Pharmaceuticals, Inc.: 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 566

DrugsSource: FDA (drug) · Date: 2026-05-27

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
ANI Pharmaceuticals, Inc.
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 / hazard
Defective Container; packets were found to be either empty or partially full.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-05-12
Code info
Lot M251109, exp Nov 2027
Product quantity
3964 Cartons
Voluntary mandated
Voluntary: Firm initiated
City
Baudette
State
MN
Country
United States
Event id
98947
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