Teva Pharmaceuticals USA Inc. has voluntarily recalled 3,772 cartons of Montelukast Sodium Oral Granules USP (4 mg), a medication used to treat asthma and allergies. The recall was initiated because the product failed quality testing for impurities, specifically degradation products known as Sulphoxide and Impurity A. This medication is the generic equivalent of Singulair.
Although no injuries have been reported, the presence of these impurities means the product may not meet safety and efficacy standards over its shelf life. Using medication that has degraded could potentially affect the management of asthma or allergy symptoms.
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Rx only medication distributed by Teva Pharmaceuticals USA, Inc.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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