Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Children's Cetirizine Hydrochloride Chewable Tablets Recalled by Sun Pharmaceutical Industries, Inc. Due to Failed Tablet/Capsule Specifications: out of specification results for...
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 Sun Pharmaceutical Industries, Inc. directly.
Affected Products
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
Quantity: 13,200 bottles
Why Was This Recalled?
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report