Drug Recalls
Recent drug recall reports from the FDA (US) and Health Canada, newest first. Each entry links to the full record -- product description, reason for recall, and severity classification -- refreshed daily.
Amerisource Health Services LLC
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Absorbine Jr. Extra Strength Multi Use Patch
Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…
FDC Limited
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
BETAHISTINE
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
IPANA 20% BENCOCAINE TOPICAL GEL
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
PD-Rx Pharmaceuticals, Inc.
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
AvKARE
Failed Dissolution Specifications
TEVA-Betahistine Tablets
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
RemedyRepack Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
PDP-Benztropine
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
Florabile
Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…
Oridermyl
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
AvKARE
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKARE
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKARE
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Curium US, LLC
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Kit for the preparation of technetium TC 99M Sestambi Injection
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
Macleods Pharmaceuticals Ltd
Failed Impurities/Degradation Specifications
Generitech Corporation
CGMP Deviations: Inconsistency in the water systems.
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
Provepharm Inc.
Discoloration
Apothecus Pharmaceutical Corp.
CGMP deviations: out of specifications for assay
Jubilant Draximage Inc., dba Jubilant Radiopharma
Failed Stability Specifications
Benzo-Jel (Cherry)
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
Rising Pharma Holding, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit