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.
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: 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
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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