# FDA recall D-0721-2026

> **Rohto-Mentholatum (Vietnam) Co., Ltd.** · Class II · drug recall initiated 2026-07-14.

## Product

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0721-2026
- **Recalling firm:** Rohto-Mentholatum (Vietnam) Co., Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-07-14
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ho Chi Minh, N/A, Vietnam

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0721-2026

## Citation

> AI Analytics. FDA recall D-0721-2026. Retrieved 2026-09-01 from https://api.ai-analytics.org/recall/D-0721-2026. Source: US FDA. Licensed CC0.

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