Class II · Moderate risk
GoodSense Aller.Ease
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
FDA drug recalls in 2021
Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,152 recalls, newest first.
Class II · Moderate risk
EQUALINE aller-ease fexofenadine hydrochloride tablets
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Cholestene capsules
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodide Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidine Iodine Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Prep Pad Large
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Prep Pad MEDIUM
SubPotent: Out of Specification
Class II · Moderate risk
Miss Slim
Marketed without ANDA/NDA approval
Class II · Moderate risk
Triamcinolone Acetonide Ointment USP
Correct Labeled Product Mispack
Class II · Moderate risk
Econazole Nitrate Cream 1%
Correct Labeled Product Mispack
Class II · Moderate risk
Tizanidine HCl Tablets
Failed Tablet/Capsule Specification: Some tablets are shaved
Class I · High risk
ALPHA MALE+ Male Enhancer
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Class II · Moderate risk
Azelaic Acid 99.0+% Micro 500 Grams
cGMP Deviations
Class II · Moderate risk
Estriol USP41 Micro 25 Grams
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30
cGMP Deviations
Class II · Moderate risk
Class I · High risk
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+
Chemical Contamination: presence of benzene
Class I · High risk
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50
Chemical Contamination: presence of benzene
Class II · Moderate risk