Class I · High risk
Xiyouji Qingzhi Capsule
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
FDA Drug Recalls
1,969 recalls, newest first
Class I · High risk
JaDera
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class II · Moderate risk
Enablex (darifenacin)
Failed Impurities/Degradation Specifications: unspecified degradation product
Class II · Moderate risk
West-ward Belladonna Alkaloids with Phenobarbital Tablets
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Class II · Moderate risk
West-ward Belladonna Alkaloids with Phenobarbital Tablets
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Ranitidine Syrup
Failed Impurity/Degradation Specification; "Related Compound C"
Class III · Low risk
Excedrin
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Class III · Low risk
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Theraflu Warming Relief
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Class III · Low risk
Maximum Strength Comtrex
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex Nighttime Cold & Cough
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class III · Low risk
Maximum Strength Comtrex Day/Night Cold & Cough
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
Class II · Moderate risk
Baxter LL bag 2% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter LL bag 1.5% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter LL bag 1% Amino Acids w/KCL
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 45 - 51 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 90+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 80+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 70+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
Class II · Moderate risk
Proplete 60 - 69 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 52 - 59 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 40 - 44 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Idpn
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.