# FDA recall D-0467-2023

> **Zydus Pharmaceuticals (USA) Inc** · Class III · drug recall initiated 2023-02-24.

## Product

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.

## 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.

## Distribution

AZ, OH, MS.

## Key facts

- **Recall number:** D-0467-2023
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-24
- **Report date:** 2023-03-22
- **Termination date:** 2025-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pennington, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0467-2023

## Citation

> AI Analytics. FDA recall D-0467-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0467-2023. Source: US FDA. Licensed CC0.

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