The recalled batches have been found to have potassium chloride that does not dissolve, which can cause high potassium levels that can lead to hypertension, heart failure, or renal dysfunction.
Glenmark Pharmaceuticals is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules 750 mg because of failed dissolution.
Potassium chloride that does not dissolve can cause patients to have high potassium levels, also known as hyperkalemia. This can result in irregular heartbeat that can lead to cardiac arrest. For patients with underlying comorbidities or conditions that cause altered potassium levels, such as hypertension, heart failure, or renal dysfunction, there is a possibility of developing hyperkalemia. This could lead to potential life threatening cardiac arrythmias, severe muscle weakness, and death.
In a news release, Glenmark said the company has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.
The batches being recalled have expiration dates from June 2024 to September 2025. A list of the products with NDC and batch numbers can be found here.