Oxycodone Hydrochloride Oral Solution — Class II drug recall D-0838-2016
Terminated recall by VistaPharm, Inc., reported 2016-05-11, distributed nationwide. Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid no
| Recall number | D-0838-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2016-04-18 |
| Classified | 2016-05-04 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2018-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 8,901 cases |
| Reason classes | packaging |
| NDC | 66689-0401-01, 66689-0401-50 |
| Lot numbers | 01/18, 435200 |
Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Reason for recall
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
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-0838-2016. 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.