# FDA recall D-0368-2022

> **Akorn, Inc.** · Class III · drug recall initiated 2021-12-03.

## Product

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34

## Reason for recall

Labeling: Missing Label

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0368-2022
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-03
- **Report date:** 2022-01-19
- **Termination date:** 2022-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0368-2022

## Citation

> AI Analytics. FDA recall D-0368-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0368-2022. Source: US FDA. Licensed CC0.

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