1,463 recalls · Class I, newest first
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Reason Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Reason Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on…
Reason Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Reason Presence of Particulate Matter: glass particulate found in vial
Reason Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Reason Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Reason Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The…
Reason Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these…
Reason Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these…
Reason Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Reason Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Reason Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Reason Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of…
Reason Subpotent Drug: found to be below the specification for labeled assay.
Reason Subpotent Drug: found to be below the specification for labeled assay.
Reason Subpotent Drug: found to be below the specification for labeled assay.
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Reason Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg…
Reason Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one…
Reason Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk