Taro Pharmaceuticals U.S.A., Inc. recalls children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120
Taro Pharmaceuticals recalls children's allergy oral solution due to undetected impurities in stability testing. Affected products contain NDC 56062-106-08, distributed by Publix. No specific remedy is listed in the recall notice.
Recall notice
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Contact the company & request your remedy
What happened, in plain English
Taro Pharmaceuticals is recalling children's allergy oral solution (cetirizine hydrochloride) because routine stability testing found an unknown impurity higher than allowed. This could pose a risk to children using the product, though the exact danger isn't specified. Read more at govinfonow.com/recall/39480-taro-children-s-allergy-oral-solution-recall-unknown-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39480-taro-children-s-allergy-oral-solution-recall-unknown-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0277-2019
Cite this page
“Taro Children's Allergy Oral Solution Recall: Unknown Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39480-taro-children-s-allergy-oral-solution-recall-unknown-impurity-risk. Based on FDA recall #D-0277-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0277-2019%22&limit=1).
Why it’s dangerous
Routine stability testing detected an impurity in the product that exceeds the specified safety limits. The exact nature of the impurity and its potential health effects are unknown, which makes it difficult to assess the risk level.
Who’s affected
Children who have purchased the recalled oral solution from Publix Super Markets. Parents or caregivers of children using this medication are most at risk.
How to tell if you have this one
Check for the product name 'children's allergy (cetirizine hydrochloride) Oral Solution', 1 mg/mL, 4 fl oz (120 mL) bottle. The NDC code is 56062-106-08, and it was distributed by Publix Super Markets with lot number 313345, expiring December 2018.
- Brand
Taro Pharmaceuticals- Product
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0276-2019 | Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.; Lot # 313342, Exp 12/18 | 12,432 bottles | — |
| D-0277-2019 | children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.; Lot # 313345, Exp 12/18 | 8328 bottles | 56062-106-08 |
| D-0278-2019 | children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.; Lot # 313344, Exp 12/18 | — | — |
What to do — step by step
Check Product Details
Look for the NDC code 56062-106-08 on the bottle label to confirm if it's the recalled product.
Questions people ask
Is there a specific remedy for this recall?
The recall notice does not specify any remedy or action steps for consumers.
What is the exact impurity found in the product?
The recall notice states that an unknown impurity higher than the specified limit was detected, but does not identify the specific impurity.
How can I confirm if my product is affected?
Check the NDC code on the bottle label; the affected product has NDC 56062-106-08 and was distributed by Publix Super Markets with lot number 313345, expiring December 2018.
Contact Taro Pharmaceuticals
We’ve drafted a message you can send Taro Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0277-2019 — Taro Pharmaceuticals children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHIST Hello, I own a children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 that is covered by recall D-0277-2019 from Taro Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0277-2019 (October 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0277-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.