FlaggedRx← Medication recall checkHome
Class III · Lower riskRecall completed

Colchicine Tablets

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.
Where it was soldAZ, OH, MS.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byZydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle foreign manufacturer
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC16714-0039-01
Show the full FDA record
Full product labelColchicine 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.
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionAZ, OH, MS.
Quantity21,936/30 count bottles and 33,096/100 count bottles
Recall initiated2023-02-24
Report date2023-03-22
Recall completed2025-07-01
Recall numberD-0467-2023
ClassificationClass III
FDA statusTerminated
Origin on filePennington NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.