RECALL DATABASE

Estradiol Gel Recall: Amneal 0.1% 0.25 mg Rx Only

Announced 2026-10-07 · FDA

Amneal Pharmaceuticals is recalling Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, distributed nationwide in the USA. The recall is due to defective containers with packets that were empty or partially full. Affected lots include Lot # 245226005B with expiration date 04/30/2028; there are 2,592 cartons involved.

BrandAmneal Pharmaceuticals, LLC
ProductEstradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.
ReasonDefective Container; packets were found to be either empty or partially full.
Severitymoderate
Units affected2592
DistributionNationwide in the USA.
AgencyFDA

WHAT YOU SHOULD DO

  1. Check your cartons for Lot # 245226005B and expiration 04/30/2028 and discontinue use if matched.
  2. Do not use the recalled gel; contact your healthcare provider or pharmacist for guidance.
  3. Follow the return or disposal instructions provided by Amneal or the FDA for recalled product.

How to identify the recalled item

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

These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.

Other estradiol gel recalls

See every estradiol gel recall →

This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.