FDA-Drug2016-10-19Class III

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

Dr. Reddy's Laboratories, Inc.
Hazard

Failed Dissolution Specifications

Sold states
nationwide
Affected count
3,858 prescription packs (115,680 capsules)
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0098-2017

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief