# FDA recall D-1332-2020

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2020-06-02.

## Product

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ

## Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

## Distribution

Product was distributed throughout the United States, including Puerto Rico.

## Key facts

- **Recall number:** D-1332-2020
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-02
- **Report date:** 2020-07-01
- **Termination date:** 2024-04-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1332-2020

## Citation

> AI Analytics. FDA recall D-1332-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1332-2020. Source: US FDA. Licensed CC0.

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