Bupropion Extended Release Tablets (American Health) – Stability Issue (2013)
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 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01
Brand
American Health Packaging
Lot Codes / Batch Numbers
The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
Products Sold
The following codes are affects by the recall: Lot #114500, Exipration Date 08/2013, repackaging date 12/04/2011.
American Health Packaging is recalling buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of due to Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.. 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 Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
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