FDA chlorthalidone dissolution testing recall covers 13,567 bottles from Inventia Healthcare after 25 mg tablets failed dissolution specifications.
More than 13,000 bottles of chlorthalidone, a prescription medication used to treat high blood pressure and fluid retention, are under a nationwide recall after tablets failed dissolution specifications.
Inventia Healthcare initiated the voluntary recall on Sept. 3. The U.S. Food and Drug Administration classified the action as a Class II recall on Sept. 17, a category used when exposure to a product could result in temporary or medically reversible health problems, while the probability of serious consequences is considered remote.
The latest recall covers 13,567 bottles of Chlorthalidone Tablets, USP, 25 mg distributed across the U.S. Each bottle contains 100 tablets and carries NDC 64980-599-01. The affected batch is RISA24002, with an expiration date of April 2027 and recall number D-0852-2026.
Failed dissolution specifications prompted recall
FDA records list failed dissolution specifications as the reason for the recall. Dissolution testing measures how a tablet breaks down and releases its active ingredient, an important part of determining whether a drug performs consistently.
A tablet failing those specifications might not release its active ingredient as intended. For patients taking chlorthalidone, the concern is less predictable drug delivery and reduced effectiveness in controlling the condition for which it was prescribed.
Chlorthalidone is a diuretic, often called a water pill. It helps the kidneys remove excess salt and water through urine and is prescribed for high blood pressure as well as fluid retention associated with certain medical conditions.
Treatment also affects fluid and electrolyte levels. Patients taking chlorthalidone are often monitored for blood pressure, kidney function and changes in sodium or potassium, while dizziness is among the possible side effects associated with the medication.
Second chlorthalidone recall from Inventia Healthcare in 2026
The September action follows an earlier Inventia Healthcare recall involving chlorthalidone tablets for the same dissolution issue. In June, the company recalled 11,460 bottles in 100-tablet and 1,000-tablet sizes, and the FDA also placed the action in Class II.
The earlier recall included lot RISA24001 in 100-count bottles under NDC 64980-599-01 and lot RISB24002 in 1,000-count bottles under NDC 64980-599-10. Both had an expiration date of April 2027.
With the latest action, Inventia Healthcare has now recalled separate chlorthalidone lots during 2026 after failures involving the way the tablets dissolve.
Patients can identify recalled chlorthalidone by checking the pharmacy label or original bottle for the NDC, lot number and expiration date. The NDC is the three-segment identifier assigned to drugs marketed in the U.S.
Patients with affected tablets are advised to speak with their pharmacist or prescribing physician rather than stopping blood pressure treatment on their own. Anyone experiencing a change in their condition or possible adverse effects should contact a healthcare provider.
Healthcare professionals and patients also have the option to report adverse events associated with the recalled product through the FDA’s MedWatch program at 1-800-FDA-1088.
