Class I · High risk
Rhino 7 Platinum 3000
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
Rhino 7 3000
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Class III · Low risk
Fenofibric Acid Tablets 105 mg
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Class III · Low risk
Fenofibric Acid Tablets
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Class I · High risk
Rhino 7 Platinum 3000
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Class I · High risk
Rhino 7 3000
Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Class I · High risk
Ultimate Herbal Slimcap Capsules
Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be tainted with undeclared sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug.
Class III · Low risk
Cetirizine HCl 10 mg Tablet
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Class I · High risk
Rhino 7 Platinum 3000
Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Class I · High risk
Rhino 7 3000
Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and dapoxetine.
Class I · High risk
ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class I · High risk
ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class II · Moderate risk
Xanax (alprazolam)
Subpotent Drug
Class I · High risk
Shorts on The Beach Golden Edition by Pink Bikini
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Class I · High risk
Shorts on The Beach Strong Formula by Pink Bikini capsules
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Class I · High risk
Pink Bikini Strong Formula capsules
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Class II · Moderate risk
Sermorelin 6mg/6mL Lyophilized Powder
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.
Class II · Moderate risk
P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility
Class II · Moderate risk
P-P-P (Cobal)
Lack of assurance of sterility