Amneal Pharmaceuticals recall: Estradiol Gel
Amneal Pharmaceuticals, LLC is recalling Estradiol Gel – 2,592 30-count cartons. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on September 8, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Estradiol Gel |
| Brand | Amneal Pharmaceuticals |
| Company | Amneal Pharmaceuticals, LLC |
| Type | Drugs |
| Classification | Class II |
| Recall date | September 8, 2026 |
| Published by FDA | October 7, 2026 |
| Quantity | 2,592 30-count cartons |
| Recall ID | 99742 |
Recalled 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.
- FDA recall number
- D-0873-2026
- Codes, lots and dates
- Lot # 245226005B, Exp Date: 04/30/2028.
- Quantity
- 2,592 30-count cartons
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99742
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Bridgewater, NJ, United States
Why it was recalled
The reason the FDA lists: “Defective Container; packets were found to be either empty or partially full.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide in the USA.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99742, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Amneal Pharmaceuticals Estradiol Gel recalled?
Yes. Amneal Pharmaceuticals, LLC recalled it on September 8, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Defective Container; packets were found to be either empty or partially full.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.