The Recall Desk
ModerateFDA (Drugs)·D-0175-2025·Announced 2025-01-08

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.

What this means for you

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
Hazard
  • mis-labeling

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.

Same brand · CARBOXYMETHYLCELLULOSE SODIUM