Class I · High risk Terminated
Levetiracetam Oral Solution 100mg/mL
Reason Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Mirtazapine Tablets
Reason 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 Terminated
Mirtazapine Tablets
Reason 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 Terminated
Silver Bullet
Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Class I · High risk Terminated
Bow & Arrow
Reason Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk Terminated
UP2, Dietary Supplement
Reason Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk Terminated
0.9% Sodium Chloride Injection
Reason Presence of Particulate Matter.
Class I · High risk Terminated
LACTATED RINGER'S Injection
Reason Presence of Particulate Matter.
Class I · High risk Terminated
Green Lumber Natural Fuel For Men capsule
Reason 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 Terminated
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk Terminated
Quinacrine Dihydrochloride
Reason Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Class I · High risk Terminated
Milk of Magnesia USP
Reason Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Class I · High risk Terminated
Drospirenone and Ethinyl Estradiol Tablets
Reason Failed dissolution specifications : failed results at the 3-month stability time point.
Class I · High risk Terminated
Fluorouracil Injection
Reason Presence of Particulate Matter; glass particulates
Class I · High risk Terminated
Hydromorphone HCl in 0.9% sodium chloride
Reason Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
Class I · High risk Terminated
Pecgen DMX Cough Suppressant Expectorant
Reason Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
Class I · High risk Terminated
Amikacin Sulfate Injection
Reason Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class I · High risk Terminated
Prochlorperazine Edisylate Injection
Reason Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class I · High risk Terminated
Promacta
Reason Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Class I · High risk Terminated
The Beast
Reason Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk Terminated
Mycophenolate Mofetil for Injection
Reason Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product