Class III · Low risk
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE
Incorrect/Undeclared Excipients.
FDA Drug Recalls
48 recalls · Class III, newest first
Class III · Low risk
Wal-Tussin DM
Incorrect/Undeclared Excipient: Product contains alcohol
Class III · Low risk
Proparacaine Hydrochloride Ophthalmic Solution
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Class III · Low risk
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Nourishing Coconut invisible solid…
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
QUIK-CARE Aerosol Foam Hand Sanitizer
Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
Class III · Low risk
Thallous Chloride TI 201 Injection
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Class III · Low risk
Bull Capsules
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
Class III · Low risk
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only
Chemical Contamination
Class III · Low risk
Norethindrone Acetate and Ethinyl Estradiol Tablets
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Class III · Low risk
Tarina Fe 1/20
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Class III · Low risk
Testosterone Cypionate 200 mg/mL in Sesame Oil
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Class III · Low risk
Hyoscyamine Sulfate Sublingual Tablets
Chemical Contamination: Bottles may contain broken dessicants
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 III · Low risk
ClomiPHENE CITRATE Tablets
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish