FDAFDA · Food and drugs·Recall number D-0543-2026
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
Published May 27, 2026 · Recall initiated: May 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container; packets were found to be either empty or partially full.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ESTRADIOL
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Distributor
- Nationwide in the USA
- UPC
- 0370954531104
- Lot
- Lot M251109, exp Nov 2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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