Class III · Low risk
Proparacaine Hydrochloride Ophthalmic Solution
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
FDA Drug Recalls
26 recalls, newest first
Class III · Low risk
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Nourishing Coconut invisible solid…
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
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
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 III · Low risk
QUIK-CARE Aerosol Foam Hand Sanitizer
Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
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
Titanium 4000
Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
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 III · Low risk
Thallous Chloride TI 201 Injection
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
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.
Class II · Moderate risk
Little Remedies New Baby Essentials Kit. Each kit contains 1 each…
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Class I · High risk
LEOPARD Miracle Honey packaged in a wooden box
Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk
Express Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Quick-Care Foam Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Moisturizing Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Advanced Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk
Gel Hand Sanitizer
Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class I · High risk
the silver bullet 10x Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil