Class III · Low risk
Tootsie Roll Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class III · Low risk
Tootsie Roll Fruit Chews Lime Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll Fruit Chews Vanilla Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll Fruit Chews Lemon Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
America's Original Dubble Bubble Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Charms Blow Pop Sour Apple Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Charms Blow Pop Blue Razz Berry Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Charms Blow Pop Watermelon Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Charms Blow Pop Cherry Scented Antibacterial Hand Gel
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dots Scented Antibacterial Hand Gel Lemon
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dots Scented Antibacterial Hand Gel Strawbrry
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dots Scented Antibacterial Hand Gel Lime
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Dots Scented Antibacterial Hand Gel Orange
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Texas Home Health Home Care Hospice Personal Care Hand Sanitizer
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN…
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Good to Go Hand Sanitizer
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Class III · Low risk
Clonidine HCL Injection
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.