# FDA recall D-0176-2025

> **AvKARE** · Class III · drug recall initiated 2024-12-18.

## Product

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15

## Reason for recall

LABELING: LABEL MIX-UP

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0176-2025
- **Recalling firm:** AvKARE
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-12-18
- **Report date:** 2025-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0176-2025

## Citation

> AI Analytics. FDA recall D-0176-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0176-2025. Source: US FDA. Licensed CC0.

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