Class III · Low risk Terminated
Wal-Tussin DM
Reason Incorrect/Undeclared Excipient: Product contains alcohol
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
Pink Pussycat SENSUAL ENHANCEMENT capsule
Reason 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 Terminated
IDArubicin Hydrochloride Injection USP 5gm/5mL
Reason Presence of Particulate Matter: Product was found to contain silica and iron oxide
Class II · Moderate risk Terminated
Preferred Pharmaceuticals
Reason Out of specification results observed in dissolution during long term stability testing.
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution 1.5% w/w
Reason 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 Terminated
Econazole Nitrate Cream
Reason 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 Terminated
Clobetasol Propionate Lotion 0.05%
Reason 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 Terminated
Lansoprazole Delayed-Release Capsules
Reason Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules
Reason Failed Dissolution Specifications; during long term stability testing.
Class II · Moderate risk Terminated
Testosterone Cypionate *gs*
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Testosterone Cypionate/ Anastrozole *gs* Oil
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
(ca) Gonadorelin
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Gonadorelin
Reason Lack of sterility assurance.
Class I · High risk Terminated
Symjepi
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class I · High risk Terminated
Symjepi
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
quinapril HCl/hydrochlorothiazide tablets
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
quinapril HCl/hydrochlorothiazide tablets
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
quinapril and hydrochlorothiazide tablets
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Accuretic
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.