The affected lot joins an earlier recall from the same manufacturer, covering the same expiration date, to bring the combined total to 25,027 bottles under two Class II actions this year, according to FDA enforcement reports cited by Healthline.
A Class II recall, in FDA classification, signals a situation where a product may cause temporary or medically reversible health consequences — not the most severe category, but not trivial when the drug in question is used to manage blood pressure, a condition where inconsistent dosing can carry real risk. Dissolution failure means the tablet may not break down at the rate required for the drug to be absorbed properly, which could leave a patient receiving less of the active compound than prescribed.
What the available information does not yet establish is how many patients may have received the affected bottles, whether any adverse events have been reported in connection with this specific lot, or why the same manufacturer's product failed the same test twice within a year on tablets sharing an expiration date. Those questions sit, for now, with the FDA and Inventia.
Marcus Azzopardi 
Harvey Jr.