The Recall Desk
ModerateFDA (Drugs)·D-0176-2025·Announced 2025-01-08

Eye drops recalled nationwide due to labeling mix-up

AvKARE is recalling Polyvinyl Alcohol Ophthalmic Solution eye drops due to a labeling mix-up. The recall affects Lot #0160 and was 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: This is an FDA Class III recall involving a labeling error (label mix-up). FDA Class III recalls are the least serious category. With no reported illnesses or injuries and only a labeling issue, this constitutes a minor labeling error corresponding to Score 2 (Moderate) per the severity rubric.

Plain-English summary

AvKARE is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4% (moisturizing lubricant eye drops) in 0.5 FL OZ (15 mL) bottles due to a labeling mix-up. The recall affects product from Lot #0160 with an expiration date of April 26, 2026. The product was distributed nationwide throughout the United States.

The U.S. Food and Drug Administration classified this as a Class III recall, indicating the lowest severity category for drug recalls.

The recalled product

Product
POLYVINYL ALCOHOL (POLYVINYL ALCOHOL)
Brand
POLYVINYL ALCOHOL
Manufacturer
AvKARE
Category
Drug — Ophthalmic
Hazard
  • label-mix-up
  • 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.

Related recalls

Same brand · POLYVINYL ALCOHOL

Same category