1,739 recalls · Class I, newest first
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 Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Reason Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in…
Reason Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Reason Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg…
Reason SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
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 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…