# FDA recall D-0883-2017

> **Dr. Reddy's Laboratories, Inc.** · Class II · drug recall initiated 2017-05-22.

## Product

Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81

## Reason for recall

Failed Dissolution Specifications: out of specification results observed for low dissolution.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0883-2017
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-22
- **Report date:** 2017-06-14
- **Termination date:** 2018-11-19

- **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-0883-2017

## Citation

> AI Analytics. FDA recall D-0883-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0883-2017. Source: US FDA. Licensed CC0.

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