Taro Recalls Children's Allergy Relief Oral Solution Due to Impurity
Taro Pharmaceuticals is recalling specific bottles of children's allergy relief oral solution because an unknown impurity exceeded safety limits during routine testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text explicitly states no illnesses or injuries were reported, and the hazard is a theoretical risk from an unknown impurity detected during routine testing, fitting the criteria for a moderate severity score.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottles. The product is distributed by Rite-Aid and was made in Israel. The recall is limited to Lot # 313344 with an expiration date of 12/18.
The recall was initiated because an unknown impurity was detected during routine stability testing at levels higher than the specified limit. The source text does not report any illnesses or injuries associated with this product.
Consumers who have this specific lot of the product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to dispose of or return the medication.
The recalled product
- Product
- 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.
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Oral Solution
- Hazard
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 # 313344
- Exp 12/18
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.
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