Thousands of bottles of a popular blood pressure medication are being recalled over concerns about effectiveness.
Inventia Healthcare Limited is voluntarily recalling 13,567 bottles of Chlorthalidone Tablets, USP, 25 mg (NDC: 64980-599-01, Batch No. RISA24002, expiration date April 2027) after they failed dissolution testing, which measures how the drug dissolves in the body.
This is the second time the company, based in India, has recalled chlorthalidone this year.
A voluntary recall happens when manufacturers or distributors “carry out their responsibility” to protect the public health of those who use their product.
Inventia Healthcare first recalled 11,460 bottles of the blood pressure medication in both 100-tablet and 1,000-tablet sizes on June 5.
The FDA identified both recalls as Class II, which is “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.”
Chlorthalidone is a diuretic, or water pill, that causes the kidneys to get rid of unnecessary salt and water by increasing urine, which helps to lower blood pressure.
When a medication fails dissolution testing, the active ingredient is not only not properly absorbed, but may also not work effectively.
Reduced efficacy of a drug to manage high blood pressure could increase the risk of stroke, heart attack, kidney damage and other complications over time.
Those who are taking the recalled medication should contact their healthcare provider before stopping taking the medication.
For class II and III recalls, the FDA states that “consumers can generally continue taking the medicine unless the recalling company provides other instructions.”
Abruptly stopping medication could be dangerous, resulting in blood pressure rising too quickly, increased risk of stroke or heart attack, kidney damage and withdrawal symptoms.
To check whether your medicine is affected, compare the lot numbers.
The batch codes for the recalled tablets are:
- RISA24001
- RISB24002
- RISA24002
The recall numbers, as posted by the FDA, are D-0852-2026 and D-0610-2026.
More than half of US adults have high blood pressure — around 119 million — with 70% or more experiencing hypertension by age 70.
Defined as a consistent reading of 130/80 milligrams of mercury (mm Hg) or higher, many people take medication to manage their condition.
The most recent guidelines from the American Heart Association and American College of Cardiology recommend taking medications sooner rather than later, depending on someone’s diagnosis and risk.
While diuretics are a commonly used medication, many people need at least two options, which may also include angiotensin-receptor blockers (ARBs), ACE inhibitors and calcium-channel blockers.
