# FDA recall D-0846-2022

> **Akorn, Inc.** · Class III · drug recall initiated 2022-04-15.

## Product

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

## Reason for recall

Failed viscosity specification - product was below specificcation

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-0846-2022
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-15
- **Report date:** 2022-05-11
- **Termination date:** 2023-09-28

- **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-0846-2022

## Citation

> AI Analytics. FDA recall D-0846-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0846-2022. Source: US FDA. Licensed CC0.

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