# FDA recall D-0077-2021

> **Preferred Pharmaceuticals, Inc.** · Class II · drug recall initiated 2020-11-01.

## Product

Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.

## Reason for recall

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

## Distribution

Distributed to two physician's offices located in FL.

## Key facts

- **Recall number:** D-0077-2021
- **Recalling firm:** Preferred Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-11-01
- **Report date:** 2020-11-25
- **Termination date:** 2024-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Anaheim, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0077-2021

## Citation

> AI Analytics. FDA recall D-0077-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0077-2021. Source: US FDA. Licensed CC0.

---

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