Quick Answer
In September 2026, the FDA classified a Class II recall of certain chlorthalidone 25 mg tablets made by Inventia Healthcare and distributed by Rising Pharma Holdings. The affected batch is lot RISA24002, NDC 64980-599-01, expiring April 2027, in 100-tablet bottles. The tablets failed a dissolution test, meaning they may not break down properly in the body. Most people taking chlorthalidone are not affected. Check your bottle’s label against the details above, and never stop taking a blood pressure medicine without talking to your doctor or pharmacist first.
The Chlorthalidone Recall 2026 has raised concerns among patients managing their high blood pressure with this medication. In September 2026, the FDA classified a Class II recall of certain chlorthalidone 25 mg tablets made by Inventia Healthcare and distributed by Rising Pharma Holdings. The affected batch is lot RISA24002, NDC 64980-599-01, expiring April 2027, in 100-tablet bottles.
What Actually Happened
Inventia Healthcare Limited, a drug manufacturer based in India, voluntarily recalled a batch of chlorthalidone 25 mg tablets. This isn’t the company’s first recall this year, either. An earlier batch was pulled back in June 2026, and now a second, separate lot has been recalled too. The most recent recall started on 3 September 2026, and the U.S. Food and Drug Administration gave it a Class II classification on 17 September 2026.
That September recall covers roughly 13,567 bottles distributed across the United States. Each bottle holds 100 tablets, and they were sold under Rising Pharma Holdings Inc.
Why Were the Tablets Recalled?
The tablets failed something called a dissolution test. In plain terms, this is a lab check that measures how quickly and how completely a tablet breaks down once it’s supposed to release its active ingredient. Think of it like a tea bag that’s supposed to release flavour quickly, but instead sits at the bottom of the cup barely steeping. If a tablet doesn’t dissolve the way it should, your body may not absorb the full dose, which could make the medicine less effective at controlling your blood pressure.
Neither the FDA nor Inventia Healthcare has shared further detail on exactly what caused the tablets to fail testing.
What Does “Class II Recall” Actually Mean?
The FDA sorts recalls into three tiers, and it helps to know where this one sits:
- Class I – the most serious category, used when a product could cause serious harm or death.
- Class II – this recall’s category, used when a product might cause temporary or reversible health effects, but serious harm is unlikely.
- Class III – the mildest category, used when a product is unlikely to cause any health problems at all.
So while this recall is worth paying attention to, it’s not in the highest-risk tier. No injuries or illnesses had been reported at the time the recall was announced.
How to Check If Your Tablets Are Affected
Grab the bottle from your medicine cabinet and look for these details:
- Product name: Chlorthalidone Tablets, USP, 25 mg
- Manufacturer: Inventia Healthcare Limited
- Lot number: RISA24002
- NDC number: 64980-599-01
- Expiry date: April 2027
- Pack size: 100 tablets per bottle, Rx only
If none of these match, your medicine almost certainly isn’t part of this recall. Chlorthalidone is also sold under other brand and generic labels by different manufacturers, and this recall applies only to this specific Inventia batch.
One thing worth knowing: if your pharmacist put your tablets into their own labelled bottle, the lot number might not be visible on what you were handed. In that case, it’s worth giving your pharmacy a quick call and asking them to check the original stock bottle for you.
What Should You Do Next?
- Check the label first. Compare it against the details above.
- Don’t stop taking your medicine on your own. Suddenly stopping a blood pressure medication can cause your blood pressure to spike, which carries its own risks. This applies even if you think your bottle might be affected.
- Call your pharmacist or GP surgery. They can confirm whether your specific bottle is part of the recall and arrange a replacement if needed.
- Watch for symptoms, such as unusually high blood pressure readings, swelling, or feeling unwell, and report anything unusual to your doctor.
- Report side effects to the FDA’s MedWatch programme if you believe you’ve been affected.
A Quick Word on Chlorthalidone Itself
Chlorthalidone is a diuretic, often nicknamed a “water pill.” It works by helping your kidneys flush out extra salt and water through urine, which in turn helps lower blood pressure and reduce fluid retention. It’s a widely prescribed, long-standing medicine, and recalls like this one are about a specific manufacturing batch, not a problem with chlorthalidone as a drug in general.
Frequently Asked Questions
Is my chlorthalidone definitely part of the recall?
Only if your bottle matches the exact lot number RISA24002 and NDC 64980-599-01. Most patients taking chlorthalidone are unaffected.
Should I stop taking my medication right away?
No. Stopping a blood pressure medicine suddenly can be risky. Speak to your pharmacist or doctor first.
What harm could the affected tablets cause?
The FDA classified this as a Class II recall, meaning temporary or reversible health effects are possible, but serious harm is considered unlikely.
Is this the first chlorthalidone recall this year?
No. An earlier, separate batch from the same manufacturer was recalled in June 2026 for a different lot.
What should I do with the recalled tablets?
Contact your pharmacy for guidance on returning or disposing of them safely, and ask about a replacement prescription.
Where can I find official updates?
The FDA’s recall database is the most reliable source for the latest status on this recall.
