Estradiol Gel Recall: ANI Pharmaceuticals Lot M251109
ANI Pharmaceuticals, Inc. is recalling Estradiol Gel, 0.1%, 0.25 mg per 0.25 g packet, 30 packets per carton, Rx only, distributed nationwide. The recall is due to defective containers with packets that are empty or partially full. About 3,964 cartons were distributed nationwide; NDC 70954-531-20; Lot M251109, exp Nov 2027.
| Brand | 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. |
| Severity | moderate |
| Units affected | 6564 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
WHAT YOU SHOULD DO
- Stop using the product from affected cartons.
- Contact ANI Pharmaceuticals for instructions on return, replacement, or refund.
- Check your cartons for Lot M251109 and expiration date Nov 2027; if you have questions, contact your healthcare provider or ANI Pharmaceuticals.
- If you experience adverse effects, report them to MedWatch.
How to identify the recalled item
| Lot / date codes | Lot M251109, exp Nov 2027 |
|---|---|
| Lot / date codes | Lot S25133A |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other estradiol gel recalls
- Estradiol Gel Recall: Amneal 0.1% 0.25 mg Rx Only · 2026-10-07
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.