FDA Recalls 13,567 Bottles of Chlorthalidone After Dissolution Test Failure

The FDA classified a voluntary recall of chlorthalidone tablets as Class II on September 17 after the blood pressure medication failed dissolution testing. Inventia Healthcare Limited, an India-based manufacturer, recalled 13,567 bottles of 25 mg chlorthalidone tablets initiated September 3. The same company issued a similar recall in June affecting 11,460 bottles. Class II designation means temporary health effects are possible but serious harm is considered remote.

What the recall covers

The recall affects Chlorthalidone Tablets, USP, 25 mg in 100-count bottles with batch number RISA24002 and April 2027 expiration date. NDC number is 64980-599-01. All 13,567 affected bottles were distributed nationwide. Patients should check their pharmacy label or original bottle for this information and contact their pharmacist or doctor if they have the recalled medication.

Why dissolution testing matters

Dissolution testing measures how well a tablet breaks down and releases its active ingredient in the body. When a drug fails this test, it may not be absorbed properly, making the medication less effective at treating high blood pressure. A tablet that doesn’t meet specifications may not release the medication as intended, potentially making its effect less predictable.

What chlorthalidone does and Class II risk

Chlorthalidone is a diuretic, or water pill, that helps kidneys remove excess sodium and water from the body to lower blood pressure and reduce fluid retention. A Class II recall means use of the product could cause temporary or medically reversible health problems, although the likelihood of serious harm is considered remote. The FDA has not reported any injuries or illnesses related to this recall.

Pattern of recalls from same manufacturer

Inventia Healthcare Limited issued a separate recall on June 5 affecting approximately 11,460 bottles of 25 mg chlorthalidone tablets, also for dissolution issues. That June recall covered batch RISB24002, also expiring April 2027. Both recalls were classified as Class II. The company initiated the September recall voluntarily and notified customers by letter.

Final Thoughts

Patients taking chlorthalidone should verify their medication batch number against the recall notice. With two recalls in three months from the same manufacturer, patients may want to discuss alternative suppliers or medications with their doctor.

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