FDA recall, , Moderate risk
ANI Pharmaceuticals Estradiol Gel
Estradiol Gel packets may be empty or partially full.
Summary by Recall Canary from the FDA notice
What happened
ANI Pharmaceuticals, Inc., of Baudette, Minnesota, is recalling Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, because packets were found to be either empty or partially full. The recall began May 12, 2026, and the product was distributed nationwide in the USA.
The product is distributed by ANI Pharmaceuticals, Inc., Baudette, MN 56623. The company recalled 3,964 cartons.
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 your packet 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, 0.1%, 0.25 mg, 0.25 g per packet
- NDC
- 70954-531-20
- Lot code
- M251109
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- ANI Pharmaceuticals, Inc.Baudette, Minnesota
- 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
- 98947
- Recall number
- D-0543-2026
- Quantity recalled
- 3964 Cartons
All recalls from ANI Pharmaceuticals, Inc.
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
In FDA's weekly enforcement report
Summary updated
