FDA Recalls 13,500 Chlorthalidone Bottles Over Dissolution Failures
The FDA has issued a Class II recall for 13,567 bottles of chlorthalidone 25mg tablets manufactured by Inventia Healthcare Limited. The recall, initially issued on September 3 and upgraded on September 17, stems from the medication failing dissolution specifications, which may prevent the drug from releasing its active ingredient properly. This is the second recall for this specific medication in three months, following a similar issue with Rising Pharma Holdings in June. Chlorthalidone is a diuretic used to treat high blood pressure and fluid retention. Patients are advised to stop using the affected product and consult their healthcare provider for an alternative.
Key points
- The FDA recalled 13,567 bottles of chlorthalidone 25mg tablets (NDC 64980-599-01, batch RISA24002, exp. 04/2027) due to failure to meet dissolution specifications.
- The recall was classified as Class II on September 17, 2026, indicating a potential for temporary or medically reversible adverse health consequences.
- This is the second recall for chlorthalidone in three months; a similar recall involving Rising Pharma Holdings occurred in June 2026 for the same reason.
- Chlorthalidone is a diuretic used to treat hypertension and fluid retention associated with heart, liver, or kidney disease.
- The affected product was distributed nationwide in 100-count bottles.
Background
This recall follows a pattern of FDA actions regarding medication quality in 2026. In August, the FDA flagged a sterility issue in Clear Eyes eye drops, leading to a recall of nearly 40,000 bottles. In September, the FDA upgraded a thyroid medication recall to Class I due to superpotency. The current chlorthalidone recall is the second for this drug in three months, highlighting recurring dissolution issues with specific manufacturers.
How outlets are covering it
AOL.com and WHIO TV both report the core facts of the recall, including the number of bottles, the manufacturer, and the reason for the recall. WHIO TV provides additional context by noting that this is the second recall for chlorthalidone in three months, referencing a similar recall in June involving Rising Pharma Holdings. Both sources agree on the Class II classification and the potential health risks, though WHIO TV explicitly defines the Class II recall level using FDA language.
Why it matters
The recall affects patients relying on chlorthalidone for hypertension and fluid retention, potentially leaving them without a critical medication. The recurrence of dissolution failures in a short timeframe raises concerns about manufacturing quality control. Patients should verify their medication lot and consult their doctor for an alternative to ensure continued treatment.
What to watch
The FDA will monitor the recall's progress and may issue further updates. Patients with the affected product should contact their healthcare provider or pharmacist for a replacement. Manufacturers may face increased scrutiny for quality control measures.
- FDA Announces New Nationwide Blood Pressure Medication Recall AOL.com
- Blood Pressure Medication Recalled Nationwide—Over 13,000 Bottles Affected EatingWell
- FDA Announces Recall on Blood Pressure Medication—More Than 13,000 Bottles Affected Nationwide Health.com
- Recall alert: 13K bottles of blood pressure medication recalled WHIO TV
- FDA Classifies Blood Pressure Medication Recall as Class II Risk SuaraGarut.ID
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