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.
American Regent, Inc.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
American Regent, Inc.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Preferred Pharmaceuticals, Inc.
cGMP Deviations
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.
Amneal Pharmaceuticals, LLC
Presence of Particulate Matter
Pharmadel, LLC
cGMP deviations
Pharmadel, LLC
cGMP deviations
Pharmadel, LLC
cGMP deviations
Pharmadel, LLC
cGMP deviations
Pharmadel, LLC
cGMP deviations
OurPharma LLC
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Pharmadel, LLC
cGMP deviations
Nubratori, Inc
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the oute…
Apollo Care, LLC
Lack of Assurance of Sterility
Life Brand Timed Release Melatonin 10mg
Labelling. Verify if your product is affected. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concern…
Riva Acetaminophen Caplet 500mg
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 c…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Breckenridge Pharmaceutical, Inc
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
SAINI TRADE INC
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sild…
SAINI TRADE INC
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
SAINI TRADE INC
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
NRA-Quetiapine XR
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 c…