220 recalls · Class I, newest first
Reason Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings…
Reason Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.
Reason Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Reason Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Reason Presence of Particulate Matter: human hair found within an internal sample syringe.
Reason Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Reason Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Reason Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Reason Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Reason Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Reason Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Reason Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved…
Reason Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Reason Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in…
Reason Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male…
Reason Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA…
Reason Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Reason Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone…
Reason Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved…