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

526 recalls, newest first

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

Thumbs Up 7 Red 70K

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

Terminated Chemical / undeclared Antoto-K D-0366-2021
Class II · Moderate risk

Thumbs Up 7 Blue 69K

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

Terminated Chemical / undeclared Bit & Bet LLC D-0388-2021
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.

Terminated Chemical / undeclared Shane Erickson Inc D-0241-2021
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.

Terminated Chemical / undeclared Shane Erickson Inc D-0240-2021
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.

Terminated Chemical / undeclared Shane Erickson Inc D-0239-2021
Class II · Moderate risk

Sildenafil Tablets USP 100 mg

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

Terminated Chemical / undeclared AVKARE Inc. NDC 42291-748-01 D-0167-2021
Class I · High risk

Red-E Tablet

Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.

Terminated Chemical / undeclared The Protein Shoppe D-1595-2020

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