More Hypokalemia Capsules Under Class I Recall

American Health Packaging, on behalf of BluePoint Laboratories, is recalling 21 lots of potassium chloride extended-release capsules for failing to meet dissolution specifications. According to the August 7, 2024, US Food and Drug Administration (FDA) Enforcement Report, the recall has been designated Class I, which 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,” American Health Packaging stated in a June 25, 2024, company announcement. “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 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 arrythmias, severe muscle weakness, and death.”

The American Health Packaging recall follows a similar Class I recall for potassium chloride extended-release capsules sold by Glenmark Pharmaceuticals Inc. USA that appeared in the July 24, 2024, FDA Enforcement Report.

The latest recall affects the following products, which were manufactured by Glenmark Pharmaceuticals Ltd. in India and distributed for BluePoint Laboratories throughout the United States: 

• potassium chloride extended-release capsules (750 mg) 10 mEq K, 100-count bottles (NDC 68001-396-00), from lots 17221738 (Exp. 7/31/24); 17222494 (Exp. 10/31/24); 17230533 (Exp. 1/31/25); and 17232208 (Exp. 9/30/25); and
• potassium chloride extended-release capsules (750 mg) 10 mEq K, 500-count bottles (NDC 68001-396-03), from lots 17221823, 17221830 (Exp. 7/31/24); 17221831 (Exp. 8/31/24); 17230248, 17230253, 17230271 (Exp. 12/31/24); 17230796, 17230820 (Exp. 2/28/25); 17230825, 17230833, 17230840 (Exp. 3/31/25); 17231537, 17231540, 17231719, 17231737 (Exp. 6/30/25); and 17232111, 17232164 (Exp. 9/30/25).

American Health Packaging voluntarily initiated the recall on June 25, 2024. The FDA issued its Class I designation on July 28, 2024. As of June 25, 2024, American Health Packaging had not received any reports of adverse events related to the recall. 

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