Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
18,012 recalls, newest first
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Amlodipine and Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets USP
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets USP
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets USP
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets USP 320 mg
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I · High risk
Montelukast Sodium Tablets 10 mg
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Class III · Low risk
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class II · Moderate risk
Megestrol Acetate Oral Suspension
Supterpotent Drug
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class III · Low risk
Diltiazem HCl Extended-release Capsules
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Class I · High risk
Living Well Remedies Weight Away Remedy
Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.