# FDA recall D-1511-2014

> **Caraco Pharmaceutical Laboratories, Ltd.** · Class II · drug recall initiated 2014-06-26.

## Product

Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.

## Reason for recall

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1511-2014
- **Recalling firm:** Caraco Pharmaceutical Laboratories, Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-06-26
- **Report date:** 2014-08-13
- **Termination date:** 2015-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Detroit, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1511-2014

## Citation

> AI Analytics. FDA recall D-1511-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1511-2014. Source: US FDA. Licensed CC0.

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