Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

111 recalls, newest first

Class II · Moderate risk

Imperial Platinum 2000

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Ongoing Chemical / undeclared QMart D-0371-2021
Class II · Moderate risk

Burro en Primavera

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Ongoing Chemical / undeclared QMart D-0370-2021
Class II · Moderate risk

PremierZen Extreme 3000

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Ongoing Chemical / undeclared QMart D-0369-2021
Class II · Moderate risk

Imperial Gold 2000

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Ongoing Chemical / undeclared QMart D-0368-2021
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.

Terminated Chemical / undeclared Ummzy, LLC D-0664-2021
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.

Terminated Chemical / undeclared Ummzy, LLC D-0663-2021
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.

Terminated Chemical / undeclared Ummzy, LLC D-0662-2021
Class II · Moderate risk

PremierZen Platinum 5000

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Ongoing Chemical / undeclared Na Na Collection D-0353-2021

Recalls by year