# FDA recall D-1079-2018

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2018-08-02.

## Product

Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05

## Reason for recall

Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1079-2018
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-02
- **Report date:** 2018-08-22
- **Termination date:** 2020-04-15

- **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-1079-2018

## Citation

> AI Analytics. FDA recall D-1079-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1079-2018. Source: US FDA. Licensed CC0.

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