Children's Loratadine Syrup — Class II drug recall D-0383-2015
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2015-02-11, distributed nationwide. Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
| Recall number | D-0383-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, United States |
| Recall initiated | 2014-12-30 |
| Classified | 2015-02-05 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2018-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 36,684 bottles |
| NDC | 51672-2092-08 |
| Lot numbers | A4105 |
| Expiration dates | 2016-12 |
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 for recall
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0383-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.