RecallRadar

FDA Drug recall D-0383-2015

Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Su…

On 2015-02-11 the FDA classified a Class II recall of Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Su… by Taro Pharmaceuticals U, citing presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0383-2015
ClassificationClass II
Statusterminated
Initiated2014-12-30
Published2015-02-11
Last updated2026-09-13 11:51 UTC
CompanyTaro Pharmaceuticals U
DistributionUS

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.

Reason

Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.

Identifiers

code_infoLot #: A4105, Exp 12/2016

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0383-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.