Class II · Moderate risk
Stanozolol 200 mg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Tri-Mix 20mcg+0.5mg+15mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Caffeine + Sodium Benzoate 500mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Tri-Mix 10mcg+0.5mg+15mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Methylcobalamin 1000mcg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class II · Moderate risk
Prostaglandin Pge-1 40mcg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
Class I · High risk
Natureal Burn Fat Nature
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
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 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
Amidate (Etomidate Injection, USP)
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
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.