Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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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

CABERGOLINE Tablets

Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life

Terminated Impurity / degradation Teva Pharmaceuticals USA, Inc. NDC 0093-5420-88 D-128-2013
Class II · Moderate risk

Carbon Dioxide

Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide.

Terminated Impurity / degradation Airgas Inc D-1371-2012
Class II · Moderate risk

Methylprednisolone Tablets

Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life

Terminated Impurity / degradation Physicians Total Care, Inc. NDC 54868-2913-03 D-1391-2012