95,114 total recalls in our database
Hot Pandeyuca & Company
During an FDA inspection, it was discovered that the label of several products failed to declare the components ingredients of a butter flavor that included allergens FD&C Yellow #5, FD&C Yellow #6 and FD&C Red #40.
Pure Edge Nutrition
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Cubist Pharmaceuticals
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
MyNicNaxs
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Dr. Reddy's Laboratories
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Pure Edge Nutrition
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine
Legacy Pharmaceutical Packaging
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
Pharmakon Pharmaceuticals
Superpotent Drug: Product contains twice the stated amount of midazolam.
Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
Pure Edge Nutrition
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine
Vitality Research Labs
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
Pure Edge Nutrition
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Pure Edge Nutrition
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein