Class II · Moderate risk
PremierZen Extreme 3000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Chemical contamination & hidden ingredients
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines.
709 FDA drug recalls with this cause, newest first.
This category covers two things the label never mentions. One is chemical contamination: benzene in sunscreens and hand sanitizers, methanol in sanitizer, lead or other heavy metals in a finished product. The other is a 'supplement' that secretly contains a prescription drug - sildenafil, tadalafil, sibutramine, phenolphthalein - so that it appears to work, at the cost of dangerous interactions the buyer cannot anticipate. A large share of these recalls are Class I, because the hidden ingredient is the whole risk.
Class II · Moderate risk
Imperial Platinum 2000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Burro en Primavera
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
PremierZen Extreme 3000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Imperial Gold 2000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class I · High risk
Thumbs up 7 Red 70K capsules
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Shogun-X capsules
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Krazy Night capsule
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class II · Moderate risk
Triple SupremeZen Gold 3500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
PremierZen Platinum 5000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class I · High risk
69MODE Blue 69 capsule
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Thumbs Up 7 White 11K capsule
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Thumbs Up 7 Black 25K capsule
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.
Class I · High risk
Shogun-X 7000 capsule
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class II · Moderate risk
Thumbs Up 7 Red 70K
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Class II · Moderate risk
Imperial Extreme 2000 Capsules
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk
PremierZen Black 5000 capsules
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk
Thumbs Up 7 Blue 69K
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Class I · High risk
Adam's Secret Extra Strength 3000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class I · High risk
Adam's Secret Extra Strength 1500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk
Metoclopramide Injection USP
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class I · High risk
TraZODONE Hydrochloride Tablets USP 100 mg
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
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