Amneal Pharmaceuticals, LLC recalls Estradiol Gel
- Recalling company
- Amneal Pharmaceuticals, LLC
- 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
- Defective Container; packets were found to be either empty or partially full.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 8, 2026
- Reported
- Oct 7, 2026
- Distribution
- Nationwide in the USA.
- Status
- Ongoing
- Quantity
- 2,592 30-count cartons
- Lot / codes
- Lot # 245226005B, Exp Date: 04/30/2028.
- Company location
- Bridgewater, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0873-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0873-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.