Class I · High risk
Nano PNC Water
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
FDA Drug Recalls
59 recalls · Class I, newest first
Class I · High risk
SLIMFIT X capsules
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Class I · High risk
MegaJex Herbal Supplement
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Class I · High risk
Domperidone capsules 10 mg
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Class I · High risk
Ultimate Body Tox PRO capsules
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Skinny Bee Diet capsules
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Class I · High risk
Lidocaine HCL/ Sodium Bicarb
Non-Sterility: failed sterility test result.
Class I · High risk
GlucaGen HypoKit
Defective delivery system: detached needles on the syringe in the kit.
Class I · High risk
Eye Wash
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Lamotrigine Orally Disintegrating Tablets
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Class I · High risk
Honeywell eyesaline Eyewash Sterile Isotonic Solution
Non Sterility; contaminated with Klebsiella pneumoniae
Class I · High risk
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I
Non-Sterility; microbial contamination identified as Bacillus circulans
Class I · High risk
Comfort Shield
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Class I · High risk
Docusate Oral 10 mg/mL Oral Syringe
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Class I · High risk
Cetylev (acetylcysteine)
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Class I · High risk
Diocto Liquid
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Class I · High risk
Super Samurai-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Ginseng Power-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Ninja-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
Tiger-X
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Class I · High risk
BLACK GOLD X ADVANCED capsules
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Class I · High risk
BLACK LABEL X capsules
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.