Estradiol Gel recall (ANI Pharmaceuticals, Inc.)
DrugClass IIOngoing
Summary: ANI Pharmaceuticals, Inc. is recalling 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.
What is being recalled
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
Why
Defective Container; packets were found to be either empty or partially full.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot M251109, exp Nov 2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0543-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 12, 2026 |
| Reported | May 27, 2026 |
| Company | ANI Pharmaceuticals, Inc. |
| Company location | Baudette, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3964 Cartons |
More recalls from ANI Pharmaceuticals, Inc. · all drug recalls · recalls from May 2026