Colchicine Tablets (Zydus) – Impurity Specification Failure (2023)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Zydus Pharmaceuticals (USA) Inc
Lot Codes / Batch Numbers
Lot #s: a) E203821, Exp. 05/2024, b) E203822, Exp. 05/2024, E206186, Exp. 10/2024, c) E203820, Exp. 05/2024.
Products Sold
Lot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.
Zydus Pharmaceuticals (USA) Inc is recalling Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets due to Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substa. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, MS, OH
Page updated: Jan 7, 2026