Class II · Moderate risk Ongoing
AMBI Skincare Fade Cream Normal Skin
Reason cGMP deviations: product stored outside of labeled temperature requirements.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily…
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Terminated
Vaccinotoxinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Tuberculinum Bovinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Tuberculinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Syphilinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Streptococcinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Pyrogenium
Reason cGMP deviations
Class II · Moderate risk Terminated
Proteus
Reason cGMP deviations
Class II · Moderate risk Terminated
Pertussinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Morbillinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Medorrhinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Influenzinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Diphtherinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Colibacillinum
Reason cGMP deviations
Class II · Moderate risk Terminated
Candida Parapsilosis
Reason cGMP deviations
Class II · Moderate risk Terminated
Candida Albicans
Reason cGMP deviations
Class II · Moderate risk Terminated
Bacillinum Pulmo
Reason cGMP deviations
Class II · Moderate risk Terminated
Anthracinum
Reason cGMP deviations
Class III · Low risk Terminated
Tivicay
Reason Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Class II · Moderate risk Terminated
Zonisamide Capsules USP
Reason CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II · Moderate risk Ongoing
Alcohol Antiseptic 80%
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class I · High risk Terminated
Anagrelide Capsules USP
Reason Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Class II · Moderate risk Terminated
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II · Moderate risk Terminated
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .