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A blood pressure medication has been recalled nationwide after the tablets failed to meet dissolution specifications, raising concerns about how effectively the drug may be absorbed.
More than 25,000 bottles of 25 mg chlorthalidone tablets from Inventia Healthcare Limited are affected by two recalls, according to information reported by USA TODAY and FDA recall records.
The recalls involve specific batches of the medication. Patients who take chlorthalidone should check their medication bottles and speak with a health care professional if they believe they have an affected product.
What blood pressure medication was recalled?
The recall affects Inventia Healthcare Limited’s 25 mg chlorthalidone tablets.
The medication was distributed in bottles containing either 100 or 1,000 tablets. The affected tablets have an expiration date of April 2027.
The recalled batch codes are:
- RISA24001
- RISB24002
- RISA24002
The FDA recall numbers are D-0610-2026 and D-0852-2026.
The first recall involved 11,460 bottles and was issued June 5. A second recall involving 13,567 bottles followed on Sept. 3.
Together, the recalls involve more than 25,000 bottles of the medication.
Why was chlorthalidone recalled?
Inventia Healthcare recalled the tablets because they failed dissolution specifications.
Dissolution refers to how a tablet breaks down so the active ingredient can become available for absorption in the body. If a medication does not dissolve as expected, it can affect how much of the active ingredient the body absorbs.
The FDA classified both recalls as Class II. According to the agency, a Class II recall involves a product that may cause temporary or medically reversible health consequences, or situations where the likelihood of serious harm is considered remote.
What is chlorthalidone used for?
Chlorthalidone is a diuretic, commonly called a water pill, that helps the body remove excess salt and water through urine.
Doctors use the medication to help lower blood pressure. It can also be used to treat fluid retention associated with certain medical conditions.
Because chlorthalidone can help control blood pressure, patients should not stop taking the medication without first speaking with their doctor or pharmacist.
What should patients do?
If you take chlorthalidone, check the medication bottle for the batch code and compare it with the recalled codes.
The FDA advises consumers to check the lot number on their medication when a recall occurs. Patients can also contact their pharmacist or health care provider for guidance.
The FDA says consumers can generally continue taking medicines involved in Class II and Class III recalls unless the recalling company gives different instructions. The agency also notes that stopping some medications can create greater health risks than continuing them.
Therefore, patients with a recalled bottle should contact their health care provider or pharmacist before making changes to their treatment.
The recall does not apply to every chlorthalidone product. It affects the specific Inventia Healthcare 25 mg tablets and batch codes listed in the recall notices.
Patients who cannot determine whether their medication is affected should ask a pharmacist to check the product details.
The FDA maintains information about current drug recalls and provides guidance for consumers checking recalled medications.
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