Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Montelukast Sodium Chewable Tablets Recalled by Macleods Pharma Usa Inc Due to Failed Dissolution Specifications: testing revealed low out of...
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 Macleods Pharma Usa Inc directly.
Affected Products
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Quantity: 10680 units
Why Was This Recalled?
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Macleods Pharma Usa Inc
Macleods Pharma Usa Inc has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report