FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing Sep 28, 2021
Reason Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint…
Class III · Low risk Ongoing Sep 28, 2021
Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class III · Low risk Ongoing Sep 28, 2021
Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class II · Moderate risk Ongoing Sep 2, 2021
Reason Labeling: Incorrect Instructions
Class II · Moderate risk Ongoing Aug 13, 2021
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk Ongoing Aug 13, 2021
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk Ongoing Aug 13, 2021
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk Ongoing Aug 13, 2021
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class I · High risk Ongoing Aug 3, 2021
Reason Superpotent Drug
Class II · Moderate risk Ongoing Jul 30, 2021
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Ongoing Jul 30, 2021
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Ongoing Jul 29, 2021
Reason Defective container: possibility for lack of seal integrity.
Class II · Moderate risk Ongoing Jul 20, 2021
Reason Marketed without ANDA/NDA approval
Class I · High risk Ongoing Jul 16, 2021
Reason Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Class II · Moderate risk Ongoing Jul 14, 2021
Reason cGMP Deviations
Class II · Moderate risk Ongoing Jul 14, 2021
Reason cGMP Deviations
Class II · Moderate risk Ongoing Jul 14, 2021
Reason cGMP Deviations
Class II · Moderate risk Ongoing Jul 14, 2021
Reason cGMP Deviations
Class II · Moderate risk Ongoing Jul 14, 2021
Reason cGMP Deviations
Class I · High risk Ongoing Jul 14, 2021
Reason Chemical Contamination: presence of benzene
Class I · High risk Ongoing Jul 14, 2021
Reason Chemical Contamination: presence of benzene
Class II · Moderate risk Ongoing Jul 14, 2021
Reason cGMP Deviations
Class II · Moderate risk Ongoing Jul 14, 2021
Reason cGMP Deviations
Class II · Moderate risk Ongoing Jul 14, 2021
Reason cGMP Deviations
Class II · Moderate risk Ongoing Jul 14, 2021
Reason cGMP Deviations