Reported May 27, 2026 · Ongoing
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals,…
ANI Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ANI Pharmaceuticals, Inc. · 210 W Main St · Baudette, MN · 56623-2467
Is this the product you have?
Estradiol Gel0.1%0.25 mg0.25 g per packet30 packets per cartonRx only
- Distributed byANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
- Lot codes and dates
Lot M251109exp Nov 2027
- Amount recalled
- 3964 Cartons
Where it was sold
- Nationwide
Why it was recalled
Defective Container; packets were found to be either empty or partially full.
This product could cause temporary or reversible health problems — stop using it.
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