Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops recall
FDA recall D-0175-2025 · initiated Dec 18, 2024
AvKARE recalled Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Ey… in Dec 2024 — an FDA Class III recall (D-0175-2025) because LABELING: LABEL MIX-UP.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
LABELING: LABEL MIX-UP
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 16,677 cartons
Details
- Product
- 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.
- Recalling company
- AvKARE
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Dec 18, 2024
- FDA report date
- Jan 8, 2025
Frequently asked
- Was Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Ey… recalled?
- AvKARE recalled Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Ey… in Dec 2024 — an FDA Class III recall (D-0175-2025) because LABELING: LABEL MIX-UP. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Ey… recalled?
- Per the FDA enforcement record, the reason for recall D-0175-2025 was: LABELING: LABEL MIX-UP
- Is a recalled Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Ey… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Ey… are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 0160, Exp. Date April 26 2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0175-2025.