children's allergy — Class II drug recall D-0277-2019
Terminated recall by Taro Pharmaceuticals U.S.A., Inc., reported 2018-11-21, distributed nationwide. Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected du
| Recall number | D-0277-2019 |
|---|---|
| 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 | 2018-10-19 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 8,328 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00041415435735 |
| NDC | 56062-0106, 56062-0106-08 |
| Lot numbers | 12/18, 313345 |
Product
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.
Reason for recall
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
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-0277-2019. 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.