Zydus Pharmaceuticals (USA) Inc. has recalled 21,936 bottles of 30-count and 33,096 bottles of 100-count Colchicine (colchicine) 0.6 mg tablets. Testing of certain batches revealed that a related substance, Beta-lumicolchicine, exceeded the allowed safety and purity specifications. While this is a low-risk recall and no injuries have been reported, patients are advised to speak with their healthcare providers regarding their treatment.
Medications that do not meet purity and degradation specifications may contain higher-than-approved levels of impurities, which can impact the quality and safety of the drug. No incidents or adverse health effects have been reported for this specific recall to date.
You have 2 options:
Manufactured for NorthStar Rx LLC and Distributed by Zydus Pharmaceuticals (USA) Inc.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.