US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 22, 2017 (9 years ago)

Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

Zenatane (isotretinoin) Capsules, USP, 40 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 55111-137-81

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
55111-137-81
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0886-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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