# FDA recall D-1428-2012

> **Zydus Pharmaceuticals USA Inc** · Class II · drug recall initiated 2012-03-14.

## Product

Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle,  Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.

## Reason for recall

Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks.  The same complainant also reported that metal shaving like material was observed on the surface of one tablet.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1428-2012
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-03-14
- **Report date:** 2012-08-08
- **Termination date:** 2013-12-17

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1428-2012

## Citation

> AI Analytics. FDA recall D-1428-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1428-2012. Source: US FDA. Licensed CC0.

---

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