FDAHealthMay 12, 2026
ANI Pharmaceuticals, Inc. — 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
⚠️ Defective Container; packets were found to be either empty or partially full.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 12, 2026
Nationwide in the USA
What's affected?
- 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
- Brand
- ESTRADIOL
- UPC
- 0370954531104
- Lot code
- M251109
Additional details
Lot M251109, exp Nov 2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3964 Cartons.
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