Estradiol Gel recall (Amneal Pharmaceuticals, LLC)
DrugClass IIOngoing
Summary: Amneal Pharmaceuticals, LLC is recalling 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.
What is being recalled
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.
Why
Defective Container; packets were found to be either empty or partially full.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA.
How to tell if yours is affected
Lot # 245226005B, Exp Date: 04/30/2028.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0873-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 8, 2026 |
| Reported | October 7, 2026 |
| Company | Amneal Pharmaceuticals, LLC |
| Company location | Bridgewater, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2,592 30-count cartons |
More recalls from Amneal Pharmaceuticals, LLC · all drug recalls · recalls from September 2026