Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Montelukast Sodium Tablets Recalled by Hetero Labs Limited Unit V Due to Discoloration: A complaint was received from a pharmacist...
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 Hetero Labs Limited Unit V directly.
Affected Products
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Quantity: 98,016 bottles
Why Was This Recalled?
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hetero Labs Limited Unit V
Hetero Labs Limited Unit V has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report