# FDA recall D-0004-2022

> **Akorn, Inc.** · Class II · drug recall initiated 2021-10-04.

## Product

Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.  Carton NDC: 17478-705-10, Bottle NDC 17478-705-11

## Reason for recall

Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0004-2022
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-10-04
- **Report date:** 2021-10-13
- **Termination date:** 2022-08-17

- **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-0004-2022

## Citation

> AI Analytics. FDA recall D-0004-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0004-2022. Source: US FDA. Licensed CC0.

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