FDA-Drug2026-10-07Class IIPACKAGING DEFECT
Amneal Estradiol Gel 0.1% recalled for defective packets, empty or partially full
Nationwide distributionDrugs
What this means
Amneal Pharmaceuticals is recalling specific lots of Estradiol Gel 0.1% because some packets in affected cartons were found to be empty or only partially filled. This means patients may not receive the correct dose of medication. The recall affects 2,592 cartons distributed nationwide.
- Check if you have Estradiol Gel from Lot #245226005B with expiration date 04/30/2028.
- Contact your pharmacy or healthcare provider if you have this product.
- Do not use affected packets; your provider can issue a replacement prescription.
The agency's original wording
Hazard
Defective Container; packets were found to be either empty or partially full.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA.
Affected count
2,592 30-count cartons
Manufactured in
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0873-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.