Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Montelukast Sodium Oral Granules Recalled by Mylan Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications; out of specification results for...
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 Mylan Pharmaceuticals Inc. directly.
Affected Products
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Quantity: 11,624 pouches
Why Was This Recalled?
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report