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 Caraco Pharmaceutical Laboratories, Ltd. Due to Failed Impurities/Degradation 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 Caraco Pharmaceutical Laboratories, Ltd. directly.
Affected Products
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
Quantity: 47,813 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Caraco Pharmaceutical Laboratories, Ltd.
Caraco Pharmaceutical Laboratories, Ltd. has 10 total recalls tracked by RecallDetector.
Related Recalls
Icosapent Ethyl Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Tablet/Capsule specifications: Red dots inside capsule and...
Zydus Pharmaceuticals (USA) Inc · March 9, 2026
Product label: Temozolomide Capsules Recalled by Rising Pharma Holding, Inc. Due to Failed Impurities/Degradation Specifications: An out-of-specification result observed during...
Rising Pharma Holding, Inc. · March 3, 2026
Semaglutide Inj. Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Tirzepatide Inj Recalled by New Life Pharma LLC Due to Lack of Assurance of Sterility
New Life Pharma LLC · February 26, 2026
Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report