CLASS III Drug recall · Reported 22 Mar 2023 · FDA Enforcement Report

Colchicine Tablets, USP 0.6 mg recalled by Zydus Pharmaceuticals (USA)

Zydus Pharmaceuticals is recalling Colchicine Tablets, USP 0.6 mg, distributed in Arizona, Mississippi, Ohio. The recall was initiated on 24 Feb 2023 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.

Quantity recalled21,936/30 count bottles and 33,096/100 count bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0467-2023
FDA event ID: 91770
Recalling firm: Zydus Pharmaceuticals, Pennington, NJ
Classification: Class III
Status: Terminated
Recall initiated: 24 Feb 2023
FDA classified: 14 Mar 2023
Reported: 22 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

24 Feb 2023	Recall initiated by company
14 Mar 2023	Classified by FDA	+18 days
22 Mar 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

AZ, OH, MS.

Arizona Mississippi Ohio

Questions about this recall

Why was it 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.

Which lots are affected?

Lot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.

Where was it sold?

AZ, OH, MS.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Zydus Pharmaceuticals

All 55

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Drug	CLASS II	Hydrocortisone Sodium Succinate for Injection recalledHydrocortisone Sodium Succinate	Zydus Pharmaceuticals	Potency & Assay	Nationwide
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 May 2026Drug	CLASS II	Erythromycin Tablets, USP, 250 mg recalledErythromycin	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 May 2026Drug	CLASS II	Erythromycin Tablets, USP, 500 mg recalledErythromycin	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
18 Mar 2026Drug	CLASS II	Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl	Zydus Pharmaceuticals	Other	Nationwide

Other Colchicine recalls

All 3

Reported	Class	Recall	Company	Reason	Where
15 Jan 2025Drug	CLASS II	Colchicine Capsules 0.6 mg recalled by Granules PharmaceuticalsColchicine	Granules Pharmaceuticals	Potency & Assay	Nationwide
22 Jan 2014Drug	CLASS II	Colchicine Tablet, 0.6 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states