Thousands of Bottles of Blood Pressure Medication Recalled Across US

Thousands of bottles of a diuretic medication used to treat high blood pressure and fluid retention are being recalled due to failed testing, according to an enforcement report published this week by the Food and Drug Administration.

India-based Inventia Healthcare Limited is recalling 13,567 bottles of generic chlorthalidone tablets, in 25-milligram strength, and 100 tablets per bottle, the report said.

The reason for the recall is due to a “failed dissolution specification,” which the FDA said has been the No. 1 reason for recalls from 2020 to 2023. It means the drug’s active ingredient did not dissolve properly, impacting the body’s ability to absorb it.

The recall notice did not provide any other details about the failed testing.

The recall was initiated on Sept. 3 and is nationwide and ongoing, according to the enforcement report.

The FDA classified the recall on Sept. 17 as Class II, or “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.” Class II is the second in a three-tiered system used by the FDA to classify recalls.

According to the U.S. government’s MedicinePlus website, chlorthalidone is classified as a diuretic, or “water pill,” that is used for the treatment of “high blood pressure and fluid retention.”

Chlorthalidone can be used to treat fluid retention, known as edema, caused by liver disease, kidney disease, or congestive heart failure, says the Mayo Clinic.

While the recall notice did not give instructions to consumers who are using the medication, the American Heart Association recommends people with high blood pressure to not “cut back or quit taking your medication” and to “never stop taking prescribed medications without consulting your healthcare professional.”

In June, Inventia Healthcare Limited separately recalled two batches of chlorthalidone tablets, also due to failed dissolution specifications, according to an enforcement report. That recall impacted 11,460 bottles of the same, 25-milligram strength medication.

The recall comes as more than 28,000 bottles of ramipril, a type of heart and blood pressure medication, were recalled nationwide due to purity concerns. Hikma Pharmaceuticals initiated the recall of the drug, which was made by Ohio-based West-Ward Columbus Inc. for Florida-based Exelan Pharmaceuticals, Inc., according to the FDA.

Last month, roughly 5,000 packages of dabigatran etexilate capsules, a medication used to reduce the risk of stroke or blood clotting in people with certain types of atrial fibrillation, were recalled due to elevated impurities. The medication was manufactured by India-based Alkem Laboratories Ltd. and distributed for Indianapolis-based Major Pharmaceuticals.