Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class I · High risk
Aphrodisiac Platinum 40000
Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
Class II · Moderate risk
GlipiZIDE Extended-release Tablets
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Class II · Moderate risk
TriMix MEDIUM
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Trimix HIGH
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test PROCYP
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test D (Testosterone Cypionate 200mg/Ml Vitamin D3 5,000iu/Ml)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Test D (Testosterone Cypionate 200mg/Ml Vitamin D3 5,000iu/Ml)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Lipoplex
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL)
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL…
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
BPlex
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
BPlex
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class I · High risk
Kopi Jantan Tradisional Natural Herbs Coffee
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class III · Low risk
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Class III · Low risk
Remifentanil HCl active pharmaceutical ingredient
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Class II · Moderate risk
Prostaglandin Tri-Mix 30:30:1 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 20:25:1 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 5:15:0.5 Injection
Lack of sterility assurance.
Class II · Moderate risk
Phenol 10% Injection
Lack of sterility assurance.