# FDA recall D-0491-2026

> **Alcon Research LLC** · Class II · drug recall initiated 2026-04-21.

## Product

Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

## Reason for recall

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0491-2026
- **Recalling firm:** Alcon Research LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-21
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Worth, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0491-2026

## Citation

> AI Analytics. FDA recall D-0491-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0491-2026. Source: US FDA. Licensed CC0.

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