Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA Drug Recalls

1,463 recalls · Class I, newest first

Class I · High risk

BD ChloraPrep Hi-Lite Orange 26 mL Applicator

Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.

Terminated Packaging defect CareFusion 213, LLC NDC 54365-400-38 D-0373-2021
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 I · High risk

Xultophy 100/3.6

Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Terminated Temperature excursion Novo Nordisk Inc NDC 0169-2911-90 D-0623-2021
Class I · High risk

TRESIBA FlexTouch

Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Terminated Temperature excursion Novo Nordisk Inc NDC 0169-2550-90 D-0621-2021
Class I · High risk

TRESIBA (insulin degludec injection)

Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Terminated Temperature excursion Novo Nordisk Inc NDC 0169-2662-90 D-0620-2021
Class I · High risk

TRESIBA FlexTouch

Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Terminated Temperature excursion Novo Nordisk Inc NDC 0169-2660-90 D-0619-2021

Recalls by year