# FDA recall D-1376-2015

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2015-08-13.

## Product

Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.

## Reason for recall

Subpotent Drug: Subpotent atorvastatin.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-1376-2015
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-08-13
- **Report date:** 2015-09-02
- **Termination date:** 2016-12-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1376-2015

## Citation

> AI Analytics. FDA recall D-1376-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1376-2015. Source: US FDA. Licensed CC0.

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