Hypokalemia Capsules Under Class I Recall

More than 50 lots of potassium chloride extended-release capsules sold by Glenmark Pharmaceuticals Inc. USA are under a Class I recall for failing to meet dissolution specifications, according to the July 24, 2024, US Food and Drug Administration (FDA) Enforcement Report. The classification is the FDA’s most significant and warns use of the affected capsules could cause serious adverse health consequences or death.

“The failed dissolution of potassium chloride extended-release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heartbeat that can lead to cardiac arrest,” Glenmark Pharmaceuticals explained in a June 24, 2024, statement. “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 … such as cardiac arrhythmias, severe muscle weakness, and death.”

The Class I recall includes the following products, which were manufactured by Glenmark Pharmaceuticals Ltd., Madhya Pradesh, India, for Glenmark Pharmaceuticals Inc., Mahwah, New Jersey, and distributed throughout the United States:

• potassium chloride extended-release capsules (750 mg) 10 mEq K, 100-count bottles (NDC 68462-357-01), from lots 17221446, 17221445 (Exp. 5/31/24); 17221393, 17221403, 17221405, 17221503, 17221508 (Exp. 6/30/24); 17221567, 17221566, 17221719, 17221731 (Exp. 7/31/24); 17221891, 17221892, 17221900, 17221992, 17222022 (Exp. 8/31/24); 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200 (Exp. 9/30/24); 17222265, 17222269 (Exp. 10/31/24); and 17222527, 17222530, 17222583, 17222586, 17230051, 17230075, 17230067 (Exp. 11/30/24); and
• potassium chloride extended-release capsules (750 mg) 10 mEq K, 500-count bottles (NDC 68462-357-05), from lots 17221197, 17221386, 17221385 (Exp. 5/31/24); 17221489, 17221504, 17221530 (Exp. 6/30/24); 17221561, 17221579, 17221568, 17221702, 17221704 (Exp. 7/31/24); 17221898, 17221993, 17222029 (Exp. 8/31/24); 17222300, 17222304, 17222278, 17222609, 17222395 (Exp. 10/31/24); and 17222589, 17222605, 17222613 (Exp. 11/30/24).

Glenmark Pharmaceuticals voluntarily initiated the recall May 30, 2024. The FDA issued its Class I designation on July 17, 2024. As of June 24, 2024, Glenmark Pharmaceuticals said it had not received any reports of hyperkalemia or serious adverse events related to the recall.

Potassium chloride extended-release capsules are available with a prescription for the treatment of patients with low potassium, or hypokalemia.