Class I · High risk
Ketorolac Trom
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
FDA Drug Recalls
50 recalls · Class I, newest first
Class I · High risk
Lamotrigine Tablets
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class I · High risk
Panther Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Rhino 7 Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Stallion Platinum 30000 Capsules in blue
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Bull Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Levetiracetam Oral Solution 100mg/mL
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Class I · High risk
Mirtazapine Tablets
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class I · High risk
Mirtazapine Tablets
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class I · High risk
Silver Bullet
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Class I · High risk
Bow & Arrow
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk
UP2, Dietary Supplement
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter.
Class I · High risk
LACTATED RINGER'S Injection
Presence of Particulate Matter.
Class I · High risk
Green Lumber Natural Fuel For Men capsule
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Class I · High risk
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk
Quinacrine Dihydrochloride
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Class I · High risk
Drospirenone and Ethinyl Estradiol Tablets
Failed dissolution specifications : failed results at the 3-month stability time point.
Class I · High risk
Fluorouracil Injection
Presence of Particulate Matter; glass particulates