Bupropion Hydrochloride Tablets (Zydus) – Dissolution Failure (2016)
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 (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Brand
Zydus Pharmaceuticals USA Inc
Lot Codes / Batch Numbers
a) MS1667 exp 01/2018, M601708, exp 03/2018, b) MS1667, MS1668, MS1669, exp 01/2018, M601515, M601516, exp 03/2018, M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018, M603988, exp 06/2018
Products Sold
a) MS1667 exp 01/2018; M601708, exp 03/2018; b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018
Zydus Pharmaceuticals USA Inc is recalling BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68 due to Failed Dissolution Specifications; 6 month time point. 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 Specifications; 6 month time point
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