Class II · Moderate risk Terminated
Candida Albicans
Reason cGMP deviations
FDA Drug Recalls
14,801 recalls, newest first
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 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 .
Class II · Moderate risk Terminated
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Xiidra
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
medroxyPROGESTERone Acetate Injectable Suspension
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By…
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Equate Tartar Control Plus
Reason Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
Class II · Moderate risk Terminated
Losartan HCTZ 50/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class III · Low risk Terminated
Sirolimus Oral Solution
Reason Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class III · Low risk Terminated
Nitrofurantoin Capsules
Reason Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.