Class II · Moderate risk
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme…
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
FDA Drug Recalls
14 recalls, newest first
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
Class I · High risk
7K capsules packaged in single packs sold in 24-count boxes
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
POSEIDON Xtreme PLATINUM 4500
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk
screamin' menthol
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class II · Moderate risk
screamin' hot
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class I · High risk
Euphoric Premium Male Performance Enhancer capsules
Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
Class I · High risk
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Red Zone Xtreme 3000 Capsules
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
Bella Capsules
Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.