Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
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
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Quantity: 128,363 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.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report