HIGH

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

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

Quick Facts at a Glance

Recall Date
May 12, 2026
Hazard Level
HIGH
Brands
ESTRADIOL, ANI Pharmaceuticals, Inc.
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact ANI Pharmaceuticals, Inc. or your healthcare provider for guidance. Notification method: Letter

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Full 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. Generic: ESTRADIOL; Brand: ESTRADIOL. Reason: Defective Container; packets were found to be either empty or partially full.. Classification: Class II. Quantity: 3964 Cartons. Distribution: Nationwide in the USA

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot M251109
exp Nov 2027
UPC Codes
70954-530
70954-531
70954-532
+12 more
Affected States
ALL
Report Date
May 27, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE