# FDA recall D-0221-2021

> **Akorn, Inc.** · Class II · drug recall initiated 2020-12-28.

## Product

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16

## Reason for recall

Defective container: Customer complaints for oral solution leaking from bottles.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0221-2021
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-28
- **Report date:** 2021-01-20
- **Termination date:** 2022-08-09

- **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-0221-2021

## Citation

> AI Analytics. FDA recall D-0221-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0221-2021. Source: US FDA. Licensed CC0.

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