Drug FDA Class III Ongoing Mislabeling
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
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)
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
CARBOXYMETHYLCELLULOSE SODIUM · 16,677 cartons
NDC: 50268-068, 50268-068-15, 50268-068-02
Code info: Lot #: 0160, Exp. Date April 26 2026
Affected areas
Nationwide
Timeline
- InitiatedDec 18, 2024
- PublishedJan 8, 2025
- Recall number
- D-0175-2025
- 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.