ANI Pharmaceuticals, Inc. recalls Estradiol Gel
- Recalling company
- ANI Pharmaceuticals, Inc.
- Product
- Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
- Reason
- Defective Container; packets were found to be either empty or partially full.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 12, 2026
- Reported
- May 27, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 3964 Cartons
- Lot / codes
- Lot M251109, exp Nov 2027
- Company location
- Baudette, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0543-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0543-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.