FDA recall, , Moderate risk
Amneal Pharmaceuticals Estradiol Gel
Estradiol Gel packets may be empty or partially full.
Summary by Recall Canary from the FDA notice
What happened
Amneal Pharmaceuticals, LLC of Bridgewater, New Jersey is recalling Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907. The FDA states the reason as Defective Container; packets were found to be either empty or partially full. The recall began September 8, 2026, and was added to the FDA's Enforcement Report on September 28, 2026. Distribution is nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Estradiol Gel
- NDC
- 69238-2452-3
- Lot code
- 245226005B
Recall details
- Company began the recall
- Sold in
Nationwide in the USA.
- Company
- Amneal Pharmaceuticals, LLCBridgewater, New Jersey
- Hazard
- Packaging defect
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99742
- Recall number
- D-0873-2026
All recalls from Amneal Pharmaceuticals, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
