Amneal Pharmaceuticals, Llc: Estradiol Gel, 0.1%, 0.25 Mg, 30-packets Per Carton

Estradiol Gel Recall Summary Amneal Pharmaceuticals is recalling Estradiol Gel 0.1% (0.25 mg packets) distributed nationwide because some packets were found to be empty or only partially filled. The affected product has NDC number 69238-2452-3 and was distributed across all U.S. states and Washington, D.C. This is a Class II recall, meaning the defective product could cause adverse health consequences.

Recalling firm
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
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-09-08
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide in the USA.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/fce4695e-4b1a-4227-a619-de884e90a7f9