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FDAFDA · Food and drugs·Recall number D-0761-2023

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86

Published May 31, 2023 · Recall initiated: May 9, 2023

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Dissolution Specifications; during stability testing

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
BUPROPION HYDROCHLORIDE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Distributor
Nationwide in the U.S.A
UPC
0347335738865
Lot
Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
Risk classification
Class II
Area (FDA)
drug
Country
United States

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