If you have a mineral or vitamin deficiency—whether you're lacking in iron, zinc, or magnesium—adding a supplement can be an easy fix. Simply add a pill to your morning routine, and you can fuel your body with the extra oomph it needs. But if your doctor recommends you take supplements for low potassium, you might want to heed a new warning from the U.S. Food and Drug Administration (FDA). Per a June 24 recall notice, 114 batches of potassium chloride supplements have been recalled.
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The recall was initiated by Glenmark Pharmaceuticals Inc., USA, which voluntarily pulled 114 batches of its Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEqK. According to the FDA notice, the products were distributed nationwide to the consumer level and retail outlets, as well as to wholesalers and distributors.
The potassium chloride supplements are being recalled due to "failed dissolution," which can lead to high potassium levels. According to the United States Pharmacopeia (USP), different supplements and medications undergo dissolution testing, which measures the "extent and rate of solution formation from a dosage form." Dissolution is also known as drug release, which is important for the treatment's effectiveness.
Having high potassium levels is formally known as hyperkalemia, and it can cause serious conditions, such as an irregular heartbeat and potentially cardiac arrest, the FDA warns.
"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 of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death," the FDA notice reads.
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Recalled potassium supplements were sold in bottles of 100-count and 500-count capsules and have expiration dates between June 2024 and Sept. 2025. A separate FDA document details all 114 of the specific product names, national drug codes (NDCs), batch numbers, and expiration dates included in the recall. You can identify recalled products using this information and the brand name "Glenmark," which is printed on the packaging.
U.S. FDA
If you have any recalled supplements at home, the FDA asks that you consult your physician or healthcare provider before you stop using them. The agency also advises you to consult a healthcare professional if you experience any issues related to the recalled potassium supplements. Any side effects or complications should be reported to the FDA's MedWatch Adverse Event Reporting program online or via regular mail or fax.
Glenmark Pharmaceuticals Inc. is actively notifying wholesalers and distributors of the recall via written letters and arranging for the return of recalled products. The FDA asks that anyone with the supplements "discontinue distribution of the recalled product lots immediately and follow the instructions provided in the written recall letter." Both wholesalers and distributors are also instructed to conduct a sub-recall to their retail and pharmacy customers.
If you have specific questions about the recall, you can reach Glenmark directly at the email address or phone number listed in the FDA notice.
