Class I · High risk Terminated
Titanium 4000
Reason Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
FENTANYL Transdermal System
Reason Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Class I · High risk Terminated
Aphrodisiac Platinum 40000
Reason Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
Class I · High risk Terminated
Kopi Jantan Tradisional Natural Herbs Coffee
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk Terminated
Lidocaine HCl Injection
Reason Presence of Particulate Matter: One vial was found to contain a hair.
Class I · High risk Terminated
8.4% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter; glass particulates
Class I · High risk Terminated
Blue Fusion Capsules
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
Class I · High risk Terminated
LEOPARD Miracle Honey packaged in a wooden box
Reason Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk Terminated
Golean DETOX capsules
Reason Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Class I · High risk Terminated
Maeng Da Kratom
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk Terminated
White Vein Kratom
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk Terminated
White Vein Kratom
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk Terminated
Maeng Da Kratom
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class I · High risk Terminated
Levoleucovorin Injection
Reason Presence of Particulate Matter: particulate matter identified as copper salts
Class I · High risk Terminated
the silver bullet 10x Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Class I · High risk Terminated
5K Premium Enhancement capsule
Reason Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Class I · High risk Terminated
Vecuronium Bromide for Injection 20 mg* *1mg/mL when…
Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class I · High risk Terminated
Vecuronium Bromide for Injection 10 mg*
Reason Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class I · High risk Terminated
Ceftriaxone for Injection USP
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk Terminated
Ceftriaxone for Injection USP
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk Terminated
Ceftriaxone for Injection USP
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk Terminated
Ceftriaxone for Injection USP
Reason Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk Terminated
Lubrisine eye drops
Reason Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Class I · High risk Terminated
Dyural-80 Injection Kit
Reason Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Class I · High risk Terminated
Dyural-40 Injection Kit
Reason Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex