Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Impurities & degradation products
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present.
704 FDA drug recalls with this cause, newest first.
Every drug has a specification for how much of each impurity or breakdown product it may contain. These recalls are lots that exceeded one of those limits - often a related compound formed during manufacturing or storage, or an out-of-specification result found during routine stability testing. Nitrosamine impurities are common enough to get their own category; everything else lands here.
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
OraVerse (Phentolamine Mesylate)
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
Class III · Low risk
Triamcinolone Acetonide Lotion
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class III · Low risk
Decitabine for Injection
Failed impurities/degradation specifications: Failure to water content and impurity
Class III · Low risk
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
methylPREDNISolone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk
methylPREDNISolone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk
methylPREDNISolone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class III · Low risk
Lynparza (olaparib)
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Class III · Low risk
Fluoxetine Tablets USP
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 75 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 25 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Atorvastatin Calcium Tablets 40 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 20 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 10 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Vecuronium bromide for Injection
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Class II · Moderate risk
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Class III · Low risk
Penicillin V Potassium for Oral Solution
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Class III · Low risk
Isradapine Capsules USP 2.5 mg
Failed Impurities/Degradation Specifications
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