Inventia Healthcare Limited recalled 13,567 bottles of chlorthalidone 25 mg after the tablets failed dissolution testing, which may affect drug absorption. The FDA has classified the recall as Class II, indicating likely temporary or reversible health consequences if there is exposure. Affected product is NDC 64980-599-01, batch RISA24002, exp. 04/2027. Patients with that batch should consult their pharmacist or clinician before changing treatment.
Over 13,000 Bottles of Chlorthalidone 25 mg Recalled After Failing Dissolution Tests
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Health authorities are reporting a nationwide recall of 13,567 bottles of the blood pressure medication chlorthalidone (25 mg) after the tablets failed dissolution specifications, which could affect how the active ingredient is released and absorbed by the body.
What Is Chlorthalidone? Chlorthalidone is a thiazide-like diuretic commonly prescribed to lower blood pressure and to treat fluid retention related to heart, kidney, or liver disease. The drug helps the kidneys remove salt and water from the blood, reducing blood volume and blood pressure.
Details of the Recall
On September 3, Inventia Healthcare Limited (India) issued a recall for 13,567 bottles of chlorthalidone tablets after laboratory testing showed the product did not meet established dissolution specifications. The U.S. Food and Drug Administration (FDA) defines "dissolution" as the ability of the active ingredient to dissolve out of the dosage form so the body can absorb it.
As of September 18, the FDA has classified this action as a Class II recall: "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
Recalled Product Identifiers
- Product: Chlorthalidone Tablets, USP (25 mg), 100 tablets per bottle
- NDC: 64980-599-01
- Batch Number: RISA24002
- Expiration Date: 04/2027
Inventia Healthcare Limited is an India-based manufacturer of generic and specialty pharmaceuticals and reports more than 40 years in operation.
What Patients Should Do
If your chlorthalidone bottle matches the NDC and batch above, do not stop or change your medication without consulting a healthcare professional. Contact your pharmacist or prescribing clinician for guidance about returning or replacing the medication and about monitoring your blood pressure while you make any change.
Note that this is the second recall affecting chlorthalidone this year: a June 2026 recall involved more than 11,000 bottles of the medication.
If you experience unexpected symptoms after taking medication from the affected batch, seek medical attention and report the issue to the FDA’s MedWatch program.
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