# FDA recall D-0838-2016

> **VistaPharm, Inc.** · Class II · drug recall initiated 2016-04-18.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0838-2016
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-04-18
- **Report date:** 2016-05-11
- **Termination date:** 2018-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Largo, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0838-2016

## Citation

> AI Analytics. FDA recall D-0838-2016. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0838-2016. Source: US FDA. Licensed CC0.

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