# FDA recall D-0441-2023

> **Teva Pharmaceuticals USA Inc** · Class II · drug recall initiated 2023-02-22.

## Product

Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60

## Reason for recall

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

## Distribution

CA

## Key facts

- **Recall number:** D-0441-2023
- **Recalling firm:** Teva Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-02-22
- **Report date:** 2023-03-15
- **Termination date:** 2023-12-06

- **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-0441-2023

## Citation

> AI Analytics. FDA recall D-0441-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0441-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*