Finasteride Tablets USP 1 mg — Class II drug recall D-0391-2023
Terminated recall by Accord Healthcare, Inc., reported 2023-03-08, distributed in PR. CGMP Deviations: recalling drug products following an FDA inspection.
| Recall number | D-0391-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-04-22 |
| Distributed | PR |
| Countries outside the US | CA |
| Quantity | 1,440,652 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00371713096902 |
| NDC | 71713-0096-90 |
| Lot numbers | P2005527, P2005528, P2005583, P2005584, P2005585, P2005586, P2005980, P2100263, P2100264, P2100396, P2101583, P2101584, P2101708, P2101711, P2102851, P2102852, P2102853, P2102854, P2102855, P2103993, P2103997, P2103998, P2103999, P2104205, P2104206, P2105546, P2105547, P2105548, P2105631, P2105632 |
| Expiration dates | 2023-09-30, 2023-10-31, 2023-12-31, 2024-02-29, 2024-04-30, 2024-08-31 |
Product
Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
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-0391-2023. 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.