Tadalafil Tablets — Class II drug recall D-0417-2023
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-0417-2023 |
|---|---|
| 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 | 613,553 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729372107, 00316729372169 |
| NDC | 16729-0369, 16729-0369-10, 16729-0369-15, 16729-0369-16, 16729-0369-17, 16729-0369-97, 16729-0370, 16729-0370-10, 16729-0370-15, 16729-0370-16, 16729-0370-17, 16729-0370-97, 16729-0371, 16729-0371-10, 16729-0371-15, 16729-0371-16, 16729-0371-17, 16729-0372, 16729-0372-10, 16729-0372-15, 16729-0372-16, 16729-0372-17 |
| Expiration dates | 2023-04-30, 2023-05-31, 2023-06-30, 2023-08-31, 2023-09-30, 2023-10-31, 2023-11-30, 2023-12-31, 2024-01-31, 2024-02-29, 2025-03-31 |
Product
Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
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-0417-2023. 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.