Estradiol Gel — Class II drug recall D-0543-2026
Ongoing recall by ANI Pharmaceuticals, Inc., reported 2026-05-27, distributed nationwide. Defective Container; packets were found to be either empty or partially full.
| Recall number | D-0543-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ANI Pharmaceuticals, Inc., Baudette, MN, United States |
| Recall initiated | 2026-05-12 |
| Classified | 2026-05-20 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 3,964 cartons |
| Reason classes | packaging |
| NDC | 70954-0530, 70954-0530-10, 70954-0530-20, 70954-0531, 70954-0531-10, 70954-0531-20, 70954-0532, 70954-0532-10, 70954-0532-20, 70954-0533, 70954-0533-10, 70954-0533-20, 70954-0534, 70954-0534-10, 70954-0534-20 |
| Lot numbers | M251109 |
| Expiration dates | 2027-11-20 |
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 for recall
Defective Container; packets were found to be either empty or partially full.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0543-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.