The Recall Desk
ModerateFDA (Drugs)·D-0383-2015·Announced 2015-02-11

Taro Recalls Children's Loratadine Syrup Due to Blue Plastic Presence

Taro Pharmaceuticals is recalling 36,684 bottles of Children's Loratadine Syrup because blue plastic was found floating in the liquid.

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, and the hazard involves a foreign substance (plastic) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 36,684 bottles of Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Grape Flavored, Sugar Free, 4 FL OZ (120 mL). The product is identified by NDC 51672-2092-8, Lot # A4105, and an expiration date of 12/2016. The recall was initiated due to the presence of a foreign substance, specifically blue plastic floating in the loratadine syrup.

The affected product was distributed nationwide. This recall is classified as Class II by the U.S. Food and Drug Administration. Consumers who have this specific lot of Children's Loratadine Syrup should stop using it and contact Taro Pharmaceuticals or their healthcare provider for further instructions.

The recalled product

Product
Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.
Affected units
36,684

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 #: A4105
  • Exp 12/2016

Distribution

Distributed nationwide across the United States.