FDA Announces 2 Recalls of Potassium Chloride Drugs Across US

Two announcements posted on the U.S. Food and Drug and Administration (FDA) website announced the recall of two potassium prescription medications.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Announcements posted on the U.S. Food and Drug Administration (FDA) website announced the recall of two potassium prescription medications due to the “failed dissolution” of both products.

Glenmark Pharmaceuticals said that the recall impacts 114 batches of 750 mg potassium chloride extended-release capsules, which are prescription-only, because the capsules “may cause high potassium levels,” known as hyperkalemia. The condition can cause an irregular heartbeat that can “lead to cardiac arrest,” the notice warned.

A second company, American Health Packaging on behalf of BluePoint Laboratories, announced a recall of 21 batches of 750 mg potassium chloride extended-release prescription capsules for the same reason.

“For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia,” the notice stated.

The potassium tables are used to treat patients who have low potassium, known as hypokalemia.

The batches of potassium chloride capsules were shipped out across the U.S. to wholesalers, distributors, and retailers, said Glenmark and BluePoint. The BluePoint lots targeted in the recall were scheduled to expire between July 2024 and September 2025, while Glenmark’s capsules will expire between June 2024 and September 2025.

To date, both Glenmark and BluePoint say they have received no reports of elevated potassium levels or of serious side effects connected to the recalled medications.

The continued use of the recalled drugs can cause the “reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death,” the notices said.

The FDA recall notice said that people taking the potassium capsules subject to the recall “should consult with their physician or health care provider before they stop using the product.”

Consumers are advised to contact their physician or health care provider if they have had any problems connected to using the drug product.

A list of products, lot numbers, and expiration dates can be found on the FDA’s website for both BluePoint’s product and Glenmark’s product.