# FDA recall D-0501-2026

> **Thea Pharma, Inc.** · Class II · drug recall initiated 2026-04-23.

## Product

Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11

## Reason for recall

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0501-2026
- **Recalling firm:** Thea Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-23
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0501-2026

## Citation

> AI Analytics. FDA recall D-0501-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0501-2026. Source: US FDA. Licensed CC0.

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