Class I · High risk
equate Magnesium Citrate
Microbial contamination of non-sterile products.
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class I · High risk
CVS Health
Microbial contamination of non-sterile products.
Class II · Moderate risk
Common Sense Fragrance Free Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Protect U Guard Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Protect U Guard Foaming Hand Sanitizer Ophardt
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Stage 2-Ophardt Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Avant Foaming Hand Sanitizer Ophardt
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Avant Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Fulvestrant Injection 250mg/5mL
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class I · High risk
Propofol Injectable Emulsion
Presence of particulate matter: particulate identified as a beetle.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk
Ativan Injection
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class III · Low risk
Tacrolimus Ointment
Defective Container: Tube split from side seam
Class II · Moderate risk
Naftifine Hydrochloride Gel
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Class III · Low risk
Crest 3D White Fluoride Anticavity Toothpaste
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Class II · Moderate risk
Aripiprazole Tablets
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Class I · High risk
Insulin Glargine
Labeling: Missing label: Label missing from some prefilled pens.
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Anticoagulant Sodium Citrate Solution
Lack of Assurance of Sterility
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility