Class IIDrug
Estradiol Gel recall
Summary
Amneal Pharmaceuticals, LLC is recalling Estradiol Gel (drug). According to the FDA report, the reason is: Defective Container; packets were found to be either empty or partially full. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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.
- Lot / code info
- Lot # 245226005B, Exp Date: 04/30/2028.
- Quantity
- 2,592 30-count cartons
- Distribution
- Nationwide in the USA.
- Recalling company
- Amneal Pharmaceuticals, LLC, Bridgewater, NJ United States
- Recall started
- September 8, 2026
- FDA report date
- October 7, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0873-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Amneal Pharmaceuticals, LLC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.