D-0873-2026Class II

Amneal Pharmaceuticals, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2026-10-07

Distribution

Nationwide in the USA.

Firm state

Product quantity

2,592 30-count cartons

Initiated by

Voluntary: Firm initiated

Reason for recall

Defective Container; packets were found to be either empty or partially full.

Product description

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.

Code / lot info

Lot # 245226005B, Exp Date: 04/30/2028.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →