Class II · Moderate risk
Magnesium Hydroxide 1200mg
CGMP Deviations: Failure to properly investigate failed microbial testing.
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
Milk of Magnesia USP
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class I · High risk
Magnesium Hydroxide 1200mg
Microbial Contamination of Non-Sterile Products
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Diclofenac Sodium Topical Solution 1.5% w/w
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Class II · Moderate risk
Econazole Nitrate Cream
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk
Clobetasol Propionate Lotion 0.05%
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules
Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk
Testosterone Cypionate *gs*
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
Testosterone Cypionate/ Anastrozole *gs* Oil
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
(ca) Gonadorelin
Lack of sterility assurance.
Class II · Moderate risk
Gonadorelin
Lack of sterility assurance.
Class I · High risk
SYMJEPI (epinephrine injection, USP)
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class I · High risk
SYMJEPI (epinephrine injection, USP)
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
quinapril HCl/hydrochlorothiazide tablets
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
quinapril HCl/hydrochlorothiazide tablets
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
quinapril and hydrochlorothiazide tablets
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk
Accuretic (quinapril HCl/hydrochlorothiazide)
CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.