Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and Recalled by Lupin Pharmaceuticals Inc. Due to CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the...
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 Lupin Pharmaceuticals Inc. directly.
Affected Products
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
Quantity: 100=29,184 bottles; 500=2922 bottles
Why Was This Recalled?
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report