Carboxymethylcellulose sodium eye drops recalled for label mix-up
AvKARE is recalling Carboxymethylcellulose Sodium Ophthalmic Solution eye drops due to a label mix-up. The recall affects 16,677 cartons distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall involving a labeling error with no reported illnesses or injuries. Per the rubric, Class III recalls typically score 1–2; a label mix-up constitutes a minor labeling error warranting a Moderate score.
Plain-English summary
AvKARE is recalling Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops (NDC 50268-068-15) due to a label mix-up. The recall affects approximately 16,677 cartons with Lot #0160 and an expiration date of April 26, 2026. This product was distributed nationwide within the United States.
The label mix-up poses a potential risk to consumers who may not receive accurate product information or usage instructions. No illnesses or injuries have been reported in connection with this recall.
Consumers who have purchased this product should stop using it and consult their healthcare provider or contact AvKARE for further guidance.
The recalled product
- Product
- CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
- Brand
- CARBOXYMETHYLCELLULOSE SODIUM
- Manufacturer
- AvKARE
- Category
- Drug — Ophthalmic / Eye Drops
- Hazard
- Affected units
- 16,677
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 0160
- Exp. Date April 26 2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by AvKARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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