# FDA recall D-0372-2021

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2021-05-04.

## Product

Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.

## Reason for recall

Presence of foreign substance: identified as activated carbon.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0372-2021
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-04
- **Report date:** 2021-05-19
- **Termination date:** 2023-06-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0372-2021

## Citation

> AI Analytics. FDA recall D-0372-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/D-0372-2021. Source: US FDA. Licensed CC0.

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