Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: customer complaints exceeded respective action limits.
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 II · Moderate risk
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Equate Tartar Control Plus
Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification for the four active ingredients.
Class II · Moderate risk
Losartan HCTZ 50/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class III · Low risk
Sirolimus Oral Solution
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class III · Low risk
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class II · Moderate risk
Losartan HCTZ 100/12.5 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
Losartan HCTZ 100/25 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Class II · Moderate risk
MVASI (bevacizumab-awwb)
Defective container: loose crimp defect, potential loss of container integrity.
Class III · Low risk
Higher Education Make Out Ready Vegan Lip Balm
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablet
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablet
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class II · Moderate risk
Xanax XR (alprazolam)
Failed Dissolution Specifications: low out of specification results for dissolution.
Class II · Moderate risk
alprazolam XR extended-release tablets
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Class III · Low risk
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic…
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Class II · Moderate risk
GaviLyte -C
Failed Stability Specification
Class II · Moderate risk
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag
CGMP Deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules
cGMP deviations
Class II · Moderate risk
Zonisamide Capsules USP
cGMP deviations
Class II · Moderate risk
Accupril (Quinapril HCl Tablets)
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.