Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Montelukast Sodium Tablets Recalled by Glenmark Generics Inc., USA Due to Chemical Contamination: The recall has been initiated based...
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 Glenmark Generics Inc., USA directly.
Affected Products
Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430.
Quantity: 591,972 bottles
Why Was This Recalled?
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Glenmark Generics Inc., USA
Glenmark Generics Inc., USA has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report