FDA (Drugs) recall action 97684
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
The agency’s own wording, quoted from the enforcement report.
Zydus is recalling 600 bottles of Entecavir Tablets USP 1 mg from one lot after an individual organic impurity returned an out-of-specification result.
Zydus is recalling 912 bottles of Entecavir Tablets USP 0.5 mg from one lot after an individual organic impurity returned an out-of-specification result.