Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, In
Summary
The FDA issued a Class II for Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, by ANI Pharmaceuticals, Inc.. Reason: Defective Container; packets were found to be either empty or partially full..
Details
Source
Drug Recall
External ID
D-0543-2026
Action Date
2026-05-27
Status
Ongoing
Category
drug
Product 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
Lot/Code Info: Lot M251109, exp Nov 2027
Quantity Affected: 3964 Cartons
Reason for Recall
Defective Container; packets were found to be either empty or partially full.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-12
Company
Baudette, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ANI Pharmaceuticals, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ANI Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ANI Pharmaceuticals, Inc. have FDA actions?
ANI Pharmaceuticals, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0543-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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