# FDA recall D-0291-2021

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2021-02-19.

## Product

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b)  500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA

## Reason for recall

Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0291-2021
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-02-19
- **Report date:** 2021-03-10
- **Termination date:** 2023-09-07

- **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-0291-2021

## Citation

> AI Analytics. FDA recall D-0291-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0291-2021. Source: US FDA. Licensed CC0.

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