Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Colchicine Tablets Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was...

Date: February 24, 2023
Company: Zydus Pharmaceuticals (USA) Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zydus Pharmaceuticals (USA) Inc directly.

Affected Products

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.

Quantity: 21,936/30 count bottles and 33,096/100 count bottles

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 3 states: AZ, MS, OH

Affected (3 states)Not affected

About Zydus Pharmaceuticals (USA) Inc

Zydus Pharmaceuticals (USA) Inc has 51 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report