Class III · Low risk
Cetirizine HCl 10 mg Tablet
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
FDA Drug Recalls
1,711 recalls, newest first
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
Class II · Moderate risk
Testosterone Cypionate
Lack of assurance of sterility
Class II · Moderate risk
Testosterone Cypionate
Lack of assurance of sterility
Class II · Moderate risk
Acetylcysteine 10% Opthalmic Solution
Lack of assurance of sterility
Class II · Moderate risk
Hydroxocobalamin 20 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Methylcobalamin
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