US Drug Recall Register
Class III · Low risk Terminated Initiated Jul 14, 2014 (12 years ago)

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.

What was recalled

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.

Recalling firm
Wockhardt Usa Inc.
NDC code
64679-101-07
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1513-2014

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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