# FDA recall D-0325-2021

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class III · drug recall initiated 2021-03-25.

## Product

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, 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

Failed Moisture Limits: Out of specification for water content

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0325-2021
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-25
- **Report date:** 2021-04-14
- **Termination date:** 2022-04-14

- **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-0325-2021

## Citation

> AI Analytics. FDA recall D-0325-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0325-2021. Source: US FDA. Licensed CC0.

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