# FDA recall D-0808-2023

> **Akorn, Inc.** · Class II · drug recall initiated 2023-04-26.

## Product

Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only,  Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.  ALL NDCs

## Reason for recall

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0808-2023
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-04-26
- **Report date:** 2023-06-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0808-2023

## Citation

> AI Analytics. FDA recall D-0808-2023. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/D-0808-2023. Source: US FDA. Licensed CC0.

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