The U.S. Food and Drug Administration has announced a nationwide recall of more than 20,000 bottles of a widely used triglyceride medication. According to information from the FDA and PIX11, Zydus Pharmaceuticals is voluntarily recalling its 1-gram Icosapent Ethyl capsules, which are sold in 120-count bottles.
The recall affects all bottles of the medication nationwide and was prompted by an oxidation issue, which could cause leakage and affect the drug’s effectiveness, as well as increase the risk of gastrointestinal side effects. Zydus Pharmaceuticals had not provided a comment when contacted by PIX11. The capsules are primarily prescribed to manage high triglyceride levels and are often used alongside a statin to reduce the risk of heart attacks, strokes, and other serious cardiovascular conditions, according to the Mayo Clinic.
EatingWell reported that the affected lot numbers include “S2520304” and “S2520333,” both expiring on February 28, 2027, as well as “S2540186,” which expires on April 30, 2027. Consumers with medication matching these lot numbers are advised to either dispose of it or return it to the pharmacy for a possible refund or replacement.
The FDA has classified this recall as a Class II recall, meaning that any adverse effects are likely to be temporary or non-severe. However, individuals who have taken the recalled medication are advised to contact a healthcare provider. Questions about the recall can also be directed to the FDA at 1-888-INFO-FDA (1-888-463-6332).
