Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Montelukast Sodium Tablets Recalled by Direct Rx Due to cGMP deviations
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 Direct Rx directly.
Affected Products
Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Quantity: 90 count: 495 bottles; 30 count: 13 bottles
Why Was This Recalled?
cGMP deviations
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Direct Rx
Direct Rx has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report