# FDA recall D-0427-2018

> **Aurobindo Pharma Ltd.** · Class III · drug recall initiated 2018-02-02.

## Product

Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only,   Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.

## Reason for recall

Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg

## Distribution

Nationwide within the US

## Key facts

- **Recall number:** D-0427-2018
- **Recalling firm:** Aurobindo Pharma Ltd.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-02
- **Report date:** 2018-02-28
- **Termination date:** 2021-02-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0427-2018

## Citation

> AI Analytics. FDA recall D-0427-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0427-2018. Source: US FDA. Licensed CC0.

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