Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Cetirizine HCl Chewable Tablet Recalled by Sandoz, Inc Due to Failed Impurities/Degradation Specifications: An out of specification (OOS)...
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, Inc directly.
Affected Products
Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06
Quantity: 1,023,430 units
Why Was This Recalled?
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sandoz, Inc
Sandoz, Inc has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report