BuPROPion Extended-release 100mg (Jubilant) – Impurity Specs (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, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Brand
Jubilant Cadista Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lot #s: a) BU15001B, BU15003D, Exp 12/16, b) BU15002A, Exp 12/16
Products Sold
Lot #s: a) BU15001B, BU15003D, Exp 12/16; b) BU15002A, Exp 12/16
Jubilant Cadista Pharmaceuticals, Inc. is recalling BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles due to Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.. 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 Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
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