# FDA recall D-1256-2015

> **Wockhardt Usa Inc.** · Class II · drug recall initiated 2015-04-22.

## Product

Amlodipine Besylate Tablets, 10 mg Tablets,   Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only.  Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

## Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

## Distribution

U.S. Nationwide including Puerto Rico.

## Key facts

- **Recall number:** D-1256-2015
- **Recalling firm:** Wockhardt Usa Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-22
- **Report date:** 2015-07-29
- **Termination date:** 2018-05-09

- **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-1256-2015

## Citation

> AI Analytics. FDA recall D-1256-2015. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1256-2015. Source: US FDA. Licensed CC0.

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