Class II · Moderate risk
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL
Lack of Assurance of Sterility
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
Class III · Low risk
Azacitidine for Injection 100mg/vial Lyophilized Powder
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class I · High risk
SANGTER Energy Supplement Capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Class I · High risk
SUSTANGO (Pendenadril Tytrate Blend)
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Class II · Moderate risk
Matzim LA (Diltiazem Hydrochloride)
Failed Dissolution Specifications: below specification limits for dissolution.
Class II · Moderate risk
Matzim LA (Diltiazem Hydrochloride)
Failed Dissolution Specifications: below specification limits for dissolution.
Class III · Low risk
Lamotrigine Tablets
Labeling: Label Error on Declared Strength
Class II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
Class II · Moderate risk
Prednisone Tablets USP
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Class II · Moderate risk
Irbesartan Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Irbesartan Tablets
Failed dissolution specifications.
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations;
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class I · High risk
Walgreens
Microbial contamination of non-sterile products.
Class I · High risk
Walgreens
Microbial contamination of non-sterile products.
Class I · High risk
Topcare health
Microbial contamination of non-sterile products.
Class I · High risk
Swan
Microbial contamination of non-sterile products.
Class I · High risk
Rexall
Microbial contamination of non-sterile products.
Class I · High risk
P, magnesium citrate SALINE LAXATIVE
Microbial contamination of non-sterile products.
Class I · High risk
meijer
Microbial contamination of non-sterile products.
Class I · High risk
Kroger
Microbial contamination of non-sterile products.
Class I · High risk
EQUALINE magnesium citrate saline laxative
Microbial contamination of non-sterile products.