Class I · High risk
LACTATED RINGER'S Injection
Presence of Particulate Matter.
FDA Drug Recalls
1,463 recalls · Class I, newest first
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
Class I · High risk
Hydromorphone HCl in 0.9% sodium chloride
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
Pecgen DMX Cough Suppressant Expectorant
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
Amikacin Sulfate Injection
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
Prochlorperazine Edisylate Injection
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
Promacta (eltrombopag)
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Class I · High risk
The Beast
Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk
Mycophenolate Mofetil for Injection
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class I · High risk
Titanium 4000
Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
Class I · High risk
FENTANYL Transdermal System
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Class I · High risk
Aphrodisiac Platinum 40000
Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
Class I · High risk
Kopi Jantan Tradisional Natural Herbs Coffee
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: One vial was found to contain a hair.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter; glass particulates
Class I · High risk
Blue Fusion Capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.