Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Montelukast Sodium Oral Granules USP Recalled by Teva Pharmaceuticals USA Inc Due to Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Teva Pharmaceuticals USA Inc directly.
Affected Products
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Quantity: 3,772 cartons
Why Was This Recalled?
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva Pharmaceuticals USA Inc
Teva Pharmaceuticals USA Inc has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report