Bupropion Hydrochloride Tablets (Sun Pharma) – dissolution failure (2015)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
Brand
Sun Pharma Global Fze
Lot Codes / Batch Numbers
Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
Products Sold
Lot #s: JKM4152A, JKM4737A, JKM5270A, Exp 08/2015
Sun Pharma Global Fze is recalling buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count due to Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 h. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026