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 (corresponding to 100 mg/mL strength)
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 drug for the treatment of male erectile dysfunction, making this an unapproved drug.
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 over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.
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 erectile dysfunchtion making this product an unapproved drug.
Reason Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
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 and acetaminophen components.
Reason Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug