FDA Drug Recalls
7 recalls · Class III, newest first
Class III · Low risk Completed Aug 7, 2024
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established…
Class III · Low risk Completed Aug 1, 2024
Reason Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Class III · Low risk Completed Jul 2, 2024
Reason Cross contamination with other products
Class III · Low risk Completed Jul 2, 2024
Reason Cross contamination with other products
Class III · Low risk Completed Apr 30, 2024
Reason Labeling: Wrong Barcode
Class III · Low risk Completed Apr 25, 2024
Reason Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Class III · Low risk Completed Mar 27, 2024
Reason Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.