FDA recall D-0873-2026 · Oct 7, 2026
Amneal Pharmaceuticals, LLC: Estradiol Gel recall
Product
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.
Reason for recall
Defective Container; packets were found to be either empty or partially full.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your package, and look for the company's notice on FDA's recalls page. If you have the product and aren't sure, don't use it until you've checked.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot # 245226005B, Exp Date: 04/30/2028.
- Quantity
- 2,592 30-count cartons
- Distribution
- Nationwide in the USA.
- Recalling firm
- Amneal Pharmaceuticals, LLC, Bridgewater, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-08
Source: openFDA enforcement record D-0873-2026 · search recall number D-0873-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 14, 2026, 12:58 AM EDT. The agency notice is the final word.
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