# FDA recall D-0419-2018

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2018-01-29.

## Product

Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

## Reason for recall

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0419-2018
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-01-29
- **Report date:** 2018-02-07
- **Termination date:** 2018-12-07

- **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-0419-2018

## Citation

> AI Analytics. FDA recall D-0419-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0419-2018. Source: US FDA. Licensed CC0.

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