# FDA recall D-0507-2017

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2017-02-15.

## Product

Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count  cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090  India, NDC 55111-136-81

## Reason for recall

Failed dissolution specifications - low dissolution  results at S3 stage.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-0507-2017
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-15
- **Report date:** 2017-03-08
- **Termination date:** 2018-12-19

- **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-0507-2017

## Citation

> AI Analytics. FDA recall D-0507-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0507-2017. Source: US FDA. Licensed CC0.

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