# FDA recall D-0786-2021

> **Akorn, Inc.** · Class II · drug recall initiated 2021-08-02.

## Product

Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045,  NDC 17478-062-35

## Reason for recall

Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.

## Distribution

Nationwide USA and Puerto Rico

## Key facts

- **Recall number:** D-0786-2021
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-02
- **Report date:** 2021-09-08
- **Termination date:** 2022-08-22

- **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-0786-2021

## Citation

> AI Analytics. FDA recall D-0786-2021. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0786-2021. Source: US FDA. Licensed CC0.

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