Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Children's Cetirizine HCl Chewable Tablets 5 mg Recalled by Sandoz Incorporated Due to Impurity/Degradation; exceeded impurity specification at the 8 and...
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 Sandoz Incorporated directly.
Affected Products
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
Quantity: 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
Why Was This Recalled?
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sandoz Incorporated
Sandoz Incorporated has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report