Unrated Drug recall · FDA · Published February 24, 2023

Zydus Colchicine Tablets 0.6mg Recall: Failed Impurities Risk

Zydus Pharmaceuticals recalls 0.6mg colchicine tablets due to failed impurities testing. Affected lots may contain unsafe levels of beta-lumicolchicine. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0467-2023Drug Zydus Pharmaceuticals ›

Recall notice

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.

Take action

Contact the company

Recalling firmZydus Pharmaceuticals (USA) Inc73 Route 31 N · Pennington, NJ 08534-3601

✎ GovInfoNow plain-language explainer

Zydus Pharmaceuticals is recalling certain 0.6mg colchicine tablets because testing found unsafe levels of a related substance called beta-lumicolchicine. This could pose a health risk if taken as directed. Read more at govinfonow.com/recall/33841-zydus-colchicine-tablets-0-6mg-recall-failed-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33841-zydus-colchicine-tablets-0-6mg-recall-failed-impurities-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0467-2023

Cite this page

“Zydus Colchicine Tablets 0.6mg Recall: Failed Impurities Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33841-zydus-colchicine-tablets-0-6mg-recall-failed-impurities-risk. Based on FDA recall #D-0467-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0467-2023%22&limit=1).

The FDA announced on Feb. 24, 2023, that Zydus Pharmaceuticals (USA) Inc voluntarily recalled Colchicine Tablets, USP 0.6 mg due to failed impurity specifications. The recall affects specific lots distributed in Arizona, Ohio, and Mississippi.

How to tell if you have it

Brand: Zydus Pharmaceuticals
Product: Colchicine Tablets, USP 0.6 mg
NDC 16714-0039-01 (30 tablets/bottle), Lot E203821, Exp. 05/2024
NDC 16714-0039-02 (100 tablets/bottle), Lots E203822 (Exp. 05/2024) and E206186 (Exp. 10/2024)
NDC 70710-1351-01 (100 tablets/bottle), Lot E203820, Exp. 05/2024

The hazard

GovInfoNow's records show the hazard involves out-of-specification results for Beta-lumicolchicine during release testing of one lot. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since 2012-03-14. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (2026-08-05), Zydus Erythromycin Tablets Recall (2026-04-29), and Zydus Recalls Icosapent Ethyl Capsules Due to Defects (2026-03-09). Other recent recalls of similar products include Alembic Fesoterodine Tablets Recall (2025-12-16), Novadoz Glycopyrrolate Oral Solution Recall (2025-12-15), and Sagent Busulfan Injection Recall (2026-05-04).

How to tell if you have this one

Check for the product name 'Colchicine Tablets, USP 0.6 mg, Rx Only' with specific lot numbers: E203821 (expiring May 2024), E203822 (expiring May 2024), or E206186 (expiring October 2024).

Brand
Zydus Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot numbers E203821, E203822, or E206186 on the bottle to confirm if your tablets are affected.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “AZ, OH, MS.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Mississippi, Ohio.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

Feb 24, 2023Firm started the recall
Mar 14, 2023FDA classified it Class III
Mar 22, 2023Published in FDA’s Enforcement Report
Jul 1, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Zydus Pharmaceuticals recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/33841-zydus-colchicine-tablets-0-6mg-recall-failed-impurities-risk">Zydus Colchicine Tablets 0.6mg Recall: Failed Impurities Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0467-2023 (February 24, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0467-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.