The Recall Desk
ModerateFDA (Drugs)·D-0277-2019·Announced 2018-11-21

Taro Recalls Children's Allergy Oral Solution Due to Impurity

Taro Pharmaceuticals is recalling 8,328 bottles of Children's Allergy (cetirizine hydrochloride) oral solution because an unknown impurity exceeded specified limits during stability testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product might cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or deaths, and the hazard is a chemical impurity detected during testing rather than a confirmed acute toxic event.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 8,328 bottles of Children's Allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, 4 FL OZ (120 mL). The product is an over-the-counter antihistamine that is dye-free and sugar-free. It was distributed nationwide in the USA by Publix Super Markets, Inc.

The recall was initiated because an unknown impurity higher than the specified limit was detected during routine stability testing. The affected product is identified by Lot # 313345 and has an expiration date of 12/18. The National Drug Code (NDC) is 56062-106-08 and the UPC is 0 41415 43573 5.

Consumers who have this product should stop using it and return it to the place of purchase or contact Taro Pharmaceuticals for further instructions.

The recalled product

Product
CHILDRENS ALLERGY (CETIRIZINE HYDROCHLORIDE)
Brand
CHILDRENS ALLERGY
Manufacturer
Taro Pharmaceuticals U.S.A., Inc.
Category
Drug — OTC Antihistamine
Hazard
Affected units
8,328

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 313345
  • Exp 12/18

UPCs (2)

  • 0041415435735
  • 041415435735

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Taro Pharmaceuticals U.S.A., Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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