# FDA recall D-1304-2020

> **AVKARE Inc.** · Class II · drug recall initiated 2020-06-04.

## Product

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478

## Reason for recall

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

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1304-2020
- **Recalling firm:** AVKARE Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-06-04
- **Report date:** 2020-06-24
- **Termination date:** 2022-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1304-2020

## Citation

> AI Analytics. FDA recall D-1304-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1304-2020. Source: US FDA. Licensed CC0.

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