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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Taro Pharmaceuticals U.S.A., Inc.: Children’s Allergy Relief Oral Solution Recalled for Potential Impurities

Agency Publication Date: November 15, 2018
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Summary

Taro Pharmaceuticals U.S.A., Inc. is recalling approximately 20,760 bottles of Children's Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL sold under the Meijer, Publix, and Rite-Aid brands. The recall was initiated because routine testing discovered an unknown impurity that exceeded safety limits. The affected products include 4-ounce bottles with expiration dates of 12/18 and were distributed nationwide at Meijer, Publix, and Rite-Aid stores. Consumers should consult their healthcare provider for guidance regarding use.

Risk

The product contains an unidentified impurity at levels higher than allowed by safety specifications, which may lead to unpredictable side effects or reduced medication effectiveness during use.

What You Should Do

  1. Check your medicine cabinet for 4 FL OZ (120 mL) bottles of Meijer Children's 24 Hour Allergy (Bubble Gum Flavor, NDC 41250-106-08) with Lot # 313342 and Exp 12/18.
  2. Check for 4 FL OZ (120 mL) bottles of Publix Children's Allergy (Dye-Free, NDC 56062-106-08) with Lot # 313345 and Exp 12/18.
  3. Check for 4 FL OZ (120 mL) bottles of Rite-Aid Children's Allergy Relief (Dye-Free, UPC 0 11822 57363 4) with Lot # 313344 and Exp 12/18.
  4. Identify your product's UPC code to confirm a match: Meijer (713733885782), Publix (041415435735), or Rite-Aid (011822573634).
  5. Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.
  6. Contact Taro Pharmaceuticals U.S.A., Inc. at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Consult healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free (4 FL OZ)
Model:
NDC 41250-106-08
UPC Codes:
713733885782
Lot Numbers:
313342 (Exp 12/18)
Date Ranges: Exp 12/18
Product: children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, Dye-Free, Sugar-Free (4 FL OZ)
Model:
NDC 56062-106-08
UPC Codes:
041415435735
Lot Numbers:
313345 (Exp 12/18)
Date Ranges: Exp 12/18
Product: children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free (4 FL OZ)
UPC Codes:
011822573634
Lot Numbers:
313344 (Exp 12/18)
Date Ranges: Exp 12/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81483
Status: Resolved
Manufacturer: Taro Pharmaceuticals U.S.A., Inc.
Sold By: Meijer; Publix; Rite-Aid
Manufactured In: United States, Israel
Units Affected: 2 products (12,432 bottles; 8328 bottles)
Distributed To: Nationwide
Agency Last Updated: November 20, 2018

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.