FDA Recalls LEADER Brand Lubricant Eye Drops Due to Non-Sterility Risk
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Although no illnesses or injuries are reported in the source material, non-sterile eye drops with confirmed bacterial contamination pose a direct and immediate risk of serious eye infection, warranting the Class I classification and a Severe severity rating.
Plain-English summary
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%) nationwide. The recall affects approximately 28,477 cartons of the product, which consists of 2 dropper bottles per carton, each containing 0.5 FL OZ (15 mL) of eye lubricant. The product is manufactured in India and distributed by Cardinal Health, Dublin, Ohio.
The FDA identified non-sterility as the reason for the recall. During the agency's investigation, the FDA found insanitary conditions at the manufacturing facility and positive bacterial test results from environmental sampling. Because this product is intended for sterile use in the eye, non-sterility poses a direct risk of serious eye infection.
Consumers who have purchased this product should stop using it immediately. Anyone who has used the recalled eye drops and experiences eye pain, redness, vision changes, or other eye symptoms should consult a healthcare provider.
The recalled product
- Product
- LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
- Brand
- LUBRICANT DROPS
- Manufacturer
- Cardinal Health Inc.
- Affected units
- 28,477
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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