Eye Drops Recalled for Non-Sterility Issues from Manufacturing Facility
Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I designation triggers Critical severity per the rubric, which explicitly lists FDA Class I as meeting the highest severity threshold.
Plain-English summary
Cardinal Health Inc. is recalling LEADER brand Eye Irritation Relief, a sterile ophthalmic eye drop product containing polyvinyl alcohol 0.5%, povidone 0.6%, and tetrahydrozoline hydrochloride 0.05% (NDC 70000-0087-1). The 0.5 FL OZ (15 mL) dropper bottles were manufactured in India.
The FDA determined the product does not meet sterility requirements. During inspection of the manufacturing facility, the FDA identified insanitary conditions and positive bacterial test results from environmental sampling.
Approximately 11,629 units were distributed nationwide in the United States. All lots of the product are affected by this recall.
Consumers who have purchased this product should stop using it immediately and speak with their healthcare provider about alternative treatment options.
The recalled product
- Product
- EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
- Brand
- EYES IRRITATION RELIEF
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic / Eye Drops
- Affected units
- 11,629
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 (1)
- ALL LOTS
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Cardinal Health Inc. 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 6 products in this recall →Related recalls
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