The FDA has classified a September recall of Inventia Healthcare's chlorthalidone 25 mg tablets as Class II; a prior June recall was also Class II. The issue is "failed dissolution specifications," meaning tablets may not dissolve properly and could deliver a reduced dose. The September recall affects more than 13,000 bottles (NDC 64980-599-01, Batch RISA24002, exp 04/2027). Do not stop your medication without consulting your healthcare provider—contact your pharmacist to confirm if your supply is affected.
FDA Classifies Nationwide Recall of Chlorthalidone 25 mg Tablets — Check Your Bottle
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The U.S. Food and Drug Administration has classified a September recall of chlorthalidone 25 mg tablets manufactured by Inventia Healthcare as Class II. An earlier recall in June for other lots was also designated Class II. If you or someone you care for takes chlorthalidone, check your prescription now to see if it is affected.
What Happened
Inventia Healthcare first recalled certain lots of chlorthalidone tablets in June and expanded the recall on September 3 to include an additional lot. On September 17 the FDA formally classified the September action as a Class II recall. The company and the FDA have attributed the recall to "failed dissolution specifications," and have not provided further technical details.
Why This Matters
Chlorthalidone is a thiazide diuretic (a "water pill") that helps the kidneys remove excess salt and water to lower blood pressure and reduce fluid buildup. If tablets do not dissolve as intended, the body may absorb less of the active ingredient, which can reduce the drug's effectiveness in controlling blood pressure. Poor control of blood pressure increases the risk of heart attack, stroke, heart failure, kidney damage, and vision problems.
FDA Class II Recall: Exposure to the product may cause temporary or medically reversible health problems, and the likelihood of serious adverse health consequences is considered remote.
Which Products Are Affected
The September recall covers more than 13,000 bottles. Check any chlorthalidone bottles you have and confirm that the label matches all of the following information:
- Product: Chlorthalidone Tablets, USP, 25 mg, 100 Tablets Per Bottle, Rx Only
- Manufacturer: Inventia Healthcare Limited
- NDC: 64980-599-01
- Batch#: RISA24002
- Expiration Date: 04/2027
If your bottle does not display each of these exact items, contact your pharmacist to confirm whether your supply is part of the recall.
What You Should Do
- Do not stop or change your medication without speaking to your healthcare provider. Abruptly stopping blood pressure medication can be harmful.
- If you believe your medication is from the recalled lot, contact your pharmacist about replacement options and next steps.
- If you experience symptoms—such as dizziness, fainting, sudden blood pressure changes, or any new or worsening illness—contact your healthcare provider immediately.
- Report any adverse effects or product quality problems to the FDA MedWatch program.
If you need help reading your label or confirming whether your prescription is affected, your pharmacist can verify NDC, batch number, and expiration date and advise on safe alternatives if necessary.
Bottom line: Check your chlorthalidone bottles now. If they match the recalled lot information above, contact your pharmacist and healthcare provider for guidance—do not stop the medication on your own.
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