Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class III · Low risk Terminated
Diltiazem HCl Extended-release Capsules
Reason Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class II · Moderate risk Terminated
Lisinopril Tablets USP
Reason Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Class I · High risk Terminated
Living Well Remedies Weight Away Remedy
Reason Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
Class II · Moderate risk Terminated
Valsartan 320 mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan 160 mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan 80 mg Tablet
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Cyclosporine 1% Human Eye Drops
Reason Lack of Process Controls
Class II · Moderate risk Terminated
ADAA Cataract Drops
Reason Lack of Process Controls
Class II · Moderate risk Terminated
Alprostadil 500 mcg/mL Injectable
Reason Incorrect Product Formulation
Class III · Low risk Terminated
Contrave
Reason Defective Container: Customer complaints of punctures in the bottle.
Class III · Low risk Terminated
Azelastine HCl Ophthalmic Solution 0.05%
Reason Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Class II · Moderate risk Completed
Camber Pharmaceuticals
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Completed
Camber Pharmaceuticals
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Completed
Camber Pharmaceuticals
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Completed
Camber Pharmaceuticals
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class III · Low risk Terminated
Diltiazem HCl Extended-Release Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class III · Low risk Terminated
Diltiazem HCl Extended-Release Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.