Class II · Moderate risk
Tri-Mix 20mcg+0.5mg+15mg/Ml
Lack of Assurance of Sterility: all sterile compounded products within expiry
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
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.
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.