Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, N
Summary
The FDA issued a Class II for Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Am by Amneal Pharmaceuticals, LLC. Reason: Defective Container; packets were found to be either empty or partially full..
Details
Source
Drug Recall
External ID
D-0873-2026
Action Date
2026-10-07
Status
Ongoing
Category
drug
Product Description
Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.
Lot/Code Info: Lot # 245226005B, Exp Date: 04/30/2028.
Quantity Affected: 2,592 30-count 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: 2026-09-08
Company
Bridgewater, NJ
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 23 drug recalls issued in the same week, part of 40 drug-related FDA actions this month.
Amneal Pharmaceuticals, LLC has 12 FDA actions in our database, including 12 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 (Amneal Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amneal Pharmaceuticals, LLC have FDA actions?
Amneal Pharmaceuticals, LLC has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0873-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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