The FDA has classified a nationwide recall of more than 13,500 bottles of chlorthalidone tablets as Class II after the blood pressure medication failed to meet dissolution specifications — the second such recall from the same manufacturer this year.
Patients taking chlorthalidone for high blood pressure should check their prescription bottles: the U.S. Food and Drug Administration has classified a nationwide recall of the medication after it failed to meet required dissolution specifications.
What’s Being Recalled
The recall covers 13,567 bottles of Chlorthalidone Tablets, USP, 25 mg, manufactured by Inventia Healthcare Limited. Each bottle contains 100 tablets and carries NDC 64980-599-01. The affected lot is RISA24002, with an expiration date of April 2027, and the action is listed under recall number D-0852-2026.
Inventia Healthcare voluntarily initiated the recall on September 3, and the FDA classified it as Class II on September 17.
Why the Recall Was Issued
The FDA says the tablets failed dissolution specifications — a standard quality test that measures how quickly and completely a medication releases its active ingredient so the body can absorb it. When a tablet doesn’t dissolve properly, it may not deliver the intended dose, potentially making the medication less effective at controlling blood pressure.
A Class II classification means the FDA considers it remotely probable that use of the product will cause serious health consequences, though it may cause temporary or medically reversible adverse effects.
Chlorthalidone is a diuretic commonly prescribed to treat high blood pressure and fluid retention.
Not the First Recall This Year
This marks the second chlorthalidone recall tied to the same dissolution issue from Inventia Healthcare in 2026. In June, the company recalled 11,460 bottles of the same medication in both 100-tablet and 1,000-tablet bottle sizes, also over failed dissolution specifications, and that recall likewise received a Class II classification from the FDA.
What Patients Should Do
Anyone currently taking chlorthalidone is encouraged to check the NDC number and lot number on their prescription bottle against the details above. Patients with questions about whether their medication is affected, or about whether to continue or stop taking it, should contact their pharmacist or prescribing physician rather than stopping the medication abruptly on their own, since suddenly discontinuing blood pressure medication can carry its own risks.
Consumers can also check the FDA’s recall database directly for the most current status and additional affected lots.
