Potassium chloride medications recalled over ‘failed dissolution’


Two brands of potassium chloride capsules are being recalled because they may not dissolve as they should, which could cause a person to have a heart attack, according to the Food and Drug Administration (FDA).

In a press release published on June 25, the FDA explained that Glenmark Pharmaceuticals Inc. is recalling 114 batches of a product called Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K. The reason is because of “failed dissolution” in the pills.

The product is intended for patients who suffer from low potassium levels, or hypokalemia. 

According to the FDA, the failed dissolution could elevate consumers’ potassium to the point where a heart attack is possible.

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Split image of white pills and heart attack

The FDA announced the recall of two different medications that, due to a failure to dissolve, have the potential to cause heart attacks. (iStock)

American Health Packaging issued a similar recall of 21 batches of the same capsules. The capsules were also made by Glenmark but distributed by BluePoint Laboratories.

“The failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest,” the FDA’s statement read. 

“For patients who require chronic use of potassium chloride extended-release oral capsules… there is a 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 agency added.

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POTASSIUM CHLORIDE LABEL

The product is intended for patients who suffer from low potassium levels, or hypokalemia. (FDA)

The FDA also noted that there have not been any hyperkalemia cases or “serious adverse events” reported related to the product yet. The statement noted that the capsules are sold in bottles of 100-count and 500-count.

“Glenmark is notifying its wholesale and distributor customers by written letters and is arranging for return of all recalled batches,” the FDA said. “Wholesalers, distributors, and retailers that have the recalled products should discontinue distribution of the recalled product lots immediately and follow the instructions provided in the written recall letter.”

“Wholesalers and distributors should conduct a sub-recall to retail or pharmacy customers.”

Potassium pills

Glenmark Pharmaceuticals Inc. is recalling 114 batches of a product called Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K. (iStock)

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Fox News Digital reached out to Glenmark Pharmaceuticals Inc. for comment, but did not hear back.



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