Eye drops recalled for non-sterility due to bacterial contamination
Cardinal Health's LEADER brand Dry Eye Relief eye drops are recalled nationwide due to non-sterility concerns. FDA found insanitary conditions and positive bacterial results from environmental sampling at 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: FDA Class I recall with confirmed non-sterility hazard (positive bacterial test results and insanitary conditions found at manufacturing facility). The FDA Class I classification mandates a minimum severity score of 4 per the rubric. No illnesses or injuries have been reported.
Plain-English summary
The LEADER brand Dry Eye Relief is an over-the-counter eye lubricant (Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3%) distributed nationwide by Cardinal Health Inc. The company is recalling all lots of the product due to non-sterility concerns.
Approximately 11,782 bottles are affected by this recall. The FDA discovered the non-sterility issue during environmental sampling at the manufacturing facility, finding insanitary conditions and positive bacterial test results.
Consumers who have purchased this product should stop using it and return it to the pharmacy where purchased for a refund or replacement. Anyone who has used the product and experiences eye symptoms should consult a healthcare provider.
This is an FDA Class I recall, the agency's most serious classification for drug recalls.
The recalled product
- Product
- DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
- Brand
- DRY EYE RELIEF
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic / Eye Drops
- Affected units
- 11,782
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
Same brand · DRY EYE RELIEF
- CriticalDrug recall: DRY EYE RELIEF eye drops for non-sterility
FDA (Drugs) · 2024-02-14
- SevereFDA Recalls Dry Eye Relief Drops Nationwide Due to Non-Sterility
FDA (Drugs) · 2024-02-14
- CriticalFDA Recalls Non-Sterile Dry Eye Relief Drops Due to Bacterial Contamination
FDA (Drugs) · 2023-11-29
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