US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 11, 2020 (6 years ago)

Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured…

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

Why it was recalled

Failed Dissolution Specifications

What was recalled

Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05

Recalling firm
Torrent Pharma Inc.
NDC code
13668-268-05
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1317-2020

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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