HydrOXYzine HYDROCHLORIDE SYRUP — Class II drug recall D-0083-2019
Terminated recall by Lannett Company, Inc., reported 2018-10-31, distributed nationwide. CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impu
| Recall number | D-0083-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lannett Company, Inc., Philadelphia, PA, United States |
| Recall initiated | 2018-10-11 |
| Classified | 2018-10-19 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2019-02-22 |
| Distributed | Nationwide (US) |
| Quantity | 8,324 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 54838-0502, 54838-0502-80 |
| Lot numbers | 10/18, 1097 |
Product
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.
Reason for recall
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
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-0083-2019. 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.