Class III · Low risk
Valsartan Tablets USP
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
FDA Drug Recalls
1,525 recalls · Class III, newest first
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 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.
Class III · Low risk
Acne Treatment Pads
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Class III · Low risk
Cicatricure
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Class III · Low risk
Well at Walgreens
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Class III · Low risk
Atorvastatin Calcium tablets
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Class III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk
Levofloxacin Injection in 5% Dextrose
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Class III · Low risk
Testosterone 200 mg Pellet
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
Class III · Low risk
Fluconazole Injection
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Class III · Low risk
Fluconazole Injection
Failed Stability Specifications: lot out of specification for elevated water vapor.
Class III · Low risk
Fluconazole Injection
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Class III · Low risk
Diazepam Rectal Gel
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Subpotent Drug
Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Class III · Low risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant