Class II · Moderate risk
Colibacillinum
cGMP deviations
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
Candida Parapsilosis
cGMP deviations
Class II · Moderate risk
Candida Albicans
cGMP deviations
Class II · Moderate risk
Bacillinum Pulmo
cGMP deviations
Class II · Moderate risk
Anthracinum
cGMP deviations
Class III · Low risk
Tivicay (dolutegravir)
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
Zonisamide Capsules USP
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II · Moderate risk
Alcohol Antiseptic 80%
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class I · High risk
Anagrelide Capsules USP
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Class II · Moderate risk
Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II · Moderate risk
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II · Moderate risk
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine…
Lack of assurance of sterility.
Class II · Moderate risk
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60…
Lack of assurance of sterility.
Class II · Moderate risk
Pyridoxine HCL 100 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Phenylephrine 1 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
PGE-3 Alprostadil 150 mcg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Ondansetron Hydrochloride
Lack of assurance of sterility.
Class II · Moderate risk
Olympia Vita-Complex Thiamine HCL
Lack of assurance of sterility.