Colchicine Tablets — Class III drug recall D-0467-2023
Terminated recall by Zydus Pharmaceuticals (USA) Inc, reported 2023-03-22, distributed in AZ, MS, OH. Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release
| Recall number | D-0467-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2023-02-24 |
| Classified | 2023-03-14 |
| Reported by FDA | 2023-03-22 |
| Terminated | 2025-07-01 |
| Distributed | AZ, MS, OH |
| Reason classes | specification failure |
| NDC | 16714-0039-01, 16714-0039-02, 70710-1351-01 |
| Expiration dates | 2024-05, 2024-10 |
Product
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 70710-1351-01, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
Reason for recall
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
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-0467-2023. 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.