Quetiapine Fumarate Tablets (American Health) – Dissolution Failure (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
Brand
American Health Packaging
Lot Codes / Batch Numbers
Lot 122600 Exp. 03/14
Products Sold
Lot 122600 Exp. 03/14
American Health Packaging is recalling QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: due to Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumar. 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 Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
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