Blood pressure drug recalled after failing FDA dissolution test
The FDA has classified a voluntary nationwide recall of certain chlorthalidone 25 mg blood pressure tablets as Class II after the pills failed dissolution testing. More than 13,000 bottles from one Inventia Healthcare lot may not dissolve properly, which could reduce how well the medication works.
Key Takeaways
- Inventia Healthcare recalled one lot of chlorthalidone 25 mg tablets on September 3, 2026, covering more than 13,000 bottles.
- The FDA classified the September action as a Class II recall on September 17 because of failed dissolution specifications.
- Affected bottles carry NDC 64980-599-01, batch RISA24002, and an April 2027 expiration date.
- Patients should contact a pharmacist or doctor before stopping or changing any blood pressure medicine.
The recall matters because chlorthalidone is a common diuretic, or “water pill,” used to treat high blood pressure. It helps the kidneys shed excess water and salt, lowering pressure and reducing risks tied to heart attack, stroke, and kidney damage. If tablets do not dissolve as intended, the body may absorb less of the active ingredient.
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What blood pressure medication was recalled?
According to Good Housekeeping’s report on the FDA action, the September recall covers chlorthalidone tablets, USP, 25 mg, sold in 100-tablet bottles and manufactured by Inventia Healthcare Limited. The specific identifiers are NDC 64980-599-01, batch number RISA24002, and expiration date 04/2027.
Inventia had already recalled certain chlorthalidone lots in June. The September 3 recall involved an additional lot. Both the June and September actions have been classified as Class II by the FDA.
Why did the FDA elevate this blood pressure recall?
Regulators listed the reason as “failed dissolution specifications.” The FDA says proper dissolution means the active ingredient dissolves from the dosage form so the body can absorb it. When that process fails, the drug may be less effective at controlling blood pressure.
A Class II recall means exposure may cause temporary or medically reversible health problems, while the chance of serious harm is considered remote. Neither Inventia Healthcare nor the FDA has released further detail beyond the dissolution finding.
What should you do if you take the recalled blood pressure pills?
Check your bottle label for the NDC, batch number, and expiration date above. If you cannot confirm the details, ask your pharmacist. Do not stop or switch treatment on your own.
Contact your healthcare provider right away if you have the recalled medication, and report any new symptoms immediately. Pharmacists can help verify whether your prescription matches batch RISA24002 and arrange a replacement if needed.