Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Janumet (sitagliptin and metformin HCl)
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Class I · High risk
The Mandalorian Hand Sanitizer
Chemical Contamination; FDA analysis found product to contain benzene
Class I · High risk
Mickey Mouse Hand Sanitizer
Chemical Contamination; FDA analysis found product to contain methanol
Class III · Low risk
Wal-Tussin DM
Incorrect/Undeclared Excipient: Product contains alcohol
Class I · High risk
Pink Pussycat SENSUAL ENHANCEMENT capsule
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
IDArubicin Hydrochloride Injection USP 5gm/5mL
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Class II · Moderate risk
Preferred Pharmaceuticals
Out of specification results observed in dissolution during long term stability testing.
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.