Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

ZENATANE (isotretinoin capsules USP) 20 mg Recalled by Dr. Reddy's Laboratories, Inc. Due to Failed Dissolution Specifications

Date: August 29, 2016
Company: Dr. Reddy's Laboratories, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Dr. Reddy's Laboratories, Inc. directly.

Affected Products

ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81

Quantity: 3,858 prescription packs (115,680 capsules)

Why Was This Recalled?

Failed Dissolution Specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Dr. Reddy's Laboratories, Inc.

Dr. Reddy's Laboratories, Inc. has 163 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report