Drug FDA Class III Ongoing Mislabeling
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
AvKARE Published Jan 8, 2025
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 40/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact AvKARE or your place of purchase with questions, and see the source record below for full details.
Reason for recall
LABELING: LABEL MIX-UP
Affected products (1)
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
POLYVINYL ALCOHOL · 0
NDC: 50268-678, 50268-678-15
Code info: Lot #: 0160, Exp. Date April 26 2026
Affected areas
Nationwide
Timeline
- InitiatedDec 18, 2024
- PublishedJan 8, 2025
- Recall number
- D-0176-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.