FDA DrugsClass II
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only,...
Published: May 27, 2026Recall ID: D-0543-2026Category: drugsCountry: US
Reason for Recall / Hazard
Defective Container; packets were found to be either empty or partially full.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Baudette |
| State | MN |
| Openfda › Nui › 1 | M0447348 |
| Openfda › Nui › 2 | N0000175825 |
| Openfda › Nui › 3 | N0000000100 |
| Openfda › Upc › 1 | 0370954531104 |
| Openfda › Upc › 2 | 0370954530107 |
| Openfda › Upc › 3 | 0370954532101 |
| Openfda › Upc › 4 | 0370954534105 |
| Openfda › Upc › 5 | 0370954533108 |
| Openfda › Unii | 4TI98Z838E |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui › 1 | 2619677 |
| Openfda › Rxcui › 2 | 2619679 |
| Openfda › Rxcui › 3 | 2619681 |
| Openfda › Rxcui › 4 | 2619683 |
| Openfda › Rxcui › 5 | 2619685 |
| Openfda › Spl id | 98963341-a7e0-4b8d-bb56-be1820611090 |
| Openfda › Brand name | ESTRADIOL |
| Openfda › Spl set id | ff28c624-906d-459c-8b8c-27cb1a664e12 |
| Openfda › Package ndc › 1 | 70954-531-10 |
| Openfda › Package ndc › 2 | 70954-531-20 |
| Openfda › Package ndc › 3 | 70954-532-10 |
| Openfda › Package ndc › 4 | 70954-532-20 |
| Openfda › Package ndc › 5 | 70954-533-10 |
| Openfda › Package ndc › 6 | 70954-533-20 |
| Openfda › Package ndc › 7 | 70954-534-10 |
| Openfda › Package ndc › 8 | 70954-534-20 |
| Openfda › Package ndc › 9 | 70954-530-10 |
| Openfda › Package ndc › 10 | 70954-530-20 |
| Openfda › Product ndc › 1 | 70954-530 |
| Openfda › Product ndc › 2 | 70954-531 |
| Openfda › Product ndc › 3 | 70954-532 |
| Openfda › Product ndc › 4 | 70954-533 |
| Openfda › Product ndc › 5 | 70954-534 |
| Openfda › Generic name | ESTRADIOL |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Estradiol Congeners [CS] |
| Openfda › Substance name | ESTRADIOL |
| Openfda › Pharm class epc | Estrogen [EPC] |
| Openfda › Pharm class moa | Estrogen Receptor Agonists [MoA] |
| Openfda › Manufacturer name | ANI Pharmaceuticals, Inc. |
| Openfda › Application number | ANDA217610 |
| Openfda › Is original packager | true |
| Event id | 98947 |
| Address 1 | 210 W Main St |
| Code info | Lot M251109, exp Nov 2027 |
| Postal code | 56623-2467 |
| Report date | 20260527 |
| Product type | Drugs |
| Product quantity | 3964 Cartons |
| Reason for recall | Defective Container; packets were found to be either empty or partially full. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260512 |
| Initial firm notification | Letter |
| Center classification date | 20260520 |
Overview
- Recalling FirmANI Pharmaceuticals, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA