Southern Oregon residents who take the prescription blood pressure medication chlorthalidone are being advised to check their medication after more than 13,500 bottles were recalled nationwide because the tablets failed federal drug-quality standards for proper dissolution.
The recall involves Chlorthalidone Tablets USP, 25 mg, manufactured by Inventia Healthcare Limited. A total of 13,567 bottles are affected. The medication was distributed nationwide, meaning pharmacies and patients in Oregon could potentially have received tablets from the affected supply.
The voluntary recall began September 3 and was classified by the U.S. Food and Drug Administration as a Class II recall on September 17. The action remains ongoing.
The affected medication was packaged in bottles containing 100 tablets and carries National Drug Code 64980-599-01. The recalled batch is RISA24002, with an expiration date of April 2027.
The reason for the recall is a failure to meet required dissolution specifications. Dissolution testing measures how a medication breaks down and releases its active ingredient. Prescription tablets are required to perform within established specifications so patients receive the intended amount of medication in a predictable manner.
For chlorthalidone, that issue is particularly relevant because the medication is commonly prescribed for long-term management of high blood pressure. It is a diuretic, sometimes called a water pill, that helps the body eliminate excess sodium and water. The drug may also be prescribed for fluid retention associated with certain medical conditions.
A tablet that does not dissolve according to its specifications may not release the medication as intended, potentially affecting how well the drug performs. The September recall has not been described as a contamination event, nor does it involve every chlorthalidone product on the market. It is limited to the identified batch.
The FDA classified the action as Class II, a category used when exposure to a recalled product may result in temporary or medically reversible health consequences, or when the likelihood of serious health consequences is considered remote. Class II is below the agency’s Class I designation, which is reserved for recalls involving a reasonable probability of serious health consequences or death.
Patients should not assume that all chlorthalidone prescriptions are affected, and they should not abruptly discontinue prescribed blood pressure medication solely because of the recall. Suddenly stopping some medications can create its own medical risks. Anyone concerned about an affected prescription should contact the pharmacy that dispensed it or the health care provider who prescribed it.
Determining whether a prescription is part of the recall may require assistance from a pharmacist. Pharmacies commonly transfer tablets from manufacturer containers into smaller prescription bottles for individual patients, and the manufacturer’s original batch number may not appear on the label provided to the patient.
Patients who have access to the original packaging can look for the 25 mg strength, NDC 64980-599-01, batch RISA24002 and an April 2027 expiration date. Those without that information can contact their dispensing pharmacy, which can check its inventory and purchasing records and determine whether replacement medication is necessary.
The September action follows a separate chlorthalidone recall earlier this year. In June, 11,460 bottles from two different batches were recalled nationwide following stability testing that identified problems involving drug potency and dissolution. Those earlier batches were RISA24001 and RISB24002 and should not be confused with the newly recalled RISA24002 batch.
For Southern Oregon patients who rely on chlorthalidone, the current recall calls for checking the medication rather than automatically stopping treatment. Anyone taking the drug who is uncertain about the manufacturer or batch should contact their pharmacist before making changes. Patients experiencing unexpected changes in blood pressure or other health concerns should contact their health care provider for medical guidance.