FDA Drug recall D-0543-2026
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 56…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class II recall of 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 56… by Ani Pharmaceuticals, citing defective Container; packets were found to be either empty or partially full.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0543-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-12 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ani Pharmaceuticals |
| Distribution | US |
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.
Identifiers
| ndc | 70954-531-10 |
|---|---|
| ndc | 70954-531-20 |
| ndc | 70954-532-10 |
| ndc | 70954-532-20 |
| ndc | 70954-533-10 |
| ndc | 70954-533-20 |
| ndc | 70954-534-10 |
| ndc | 70954-534-20 |
| ndc | 70954-530-10 |
| ndc | 70954-530-20 |
| code_info | Lot M251109, exp Nov 2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0543-2026%22
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