Class II · Moderate risk
Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
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.
Class II · Moderate risk
Valsartan 320 mg Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan 160 mg Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan 80 mg Tablet
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Cyclosporine 1% Human Eye Drops
Lack of Process Controls
Class II · Moderate risk
ADAA Cataract Drops
Lack of Process Controls
Class II · Moderate risk
Alprostadil 500 mcg/mL Injectable
Incorrect Product Formulation
Class III · Low risk
Contrave (naltrexone HCl and bupropion HCl)
Defective Container: Customer complaints of punctures in the bottle.
Class III · Low risk
Azelastine HCl Ophthalmic Solution 0.05%
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Class II · Moderate risk
Camber Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Camber Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Camber Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Camber Pharmaceuticals
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 test results obtained during routine stability testing for related compound.
Class III · Low risk
Diltiazem HCl Extended-Release Capsules
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.