# FDA recall D-1303-2020

> **Apotex Inc.** · Class II · drug recall initiated 2020-05-27.

## Product

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1

## Reason for recall

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

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1303-2020
- **Recalling firm:** Apotex Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2020-05-27
- **Report date:** 2020-06-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North York, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1303-2020

## Citation

> AI Analytics. FDA recall D-1303-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1303-2020. Source: US FDA. Licensed CC0.

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