FDA Drug recall D-0838-2016
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 (…
- FDA Drug
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of 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 (… by Vistapharm, citing defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0838-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-18 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vistapharm |
| Distribution | US |
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
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Identifiers
| code_info | Lot # 435200, EXP 01/18 |
|---|
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-0838-2016%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.