FDA Recalls Non-Sterile Dry Eye Relief Drops Due to Bacterial Contamination
Cardinal Health is recalling all lots of LEADER brand Dry Eye Relief nationwide due to non-sterility. FDA found insanitary manufacturing conditions and positive bacterial test results.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recall for a non-sterile ophthalmic product with confirmed positive bacterial contamination. Non-sterile eye drops pose a reasonable probability of serious ocular infections and potential vision-threatening complications.
Plain-English summary
The FDA has issued a Class I recall of LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), distributed by Cardinal Health Inc. Approximately 21,802 bottles of the 0.5 FL OZ (15 mL) dropper bottles have been recalled nationwide.
The recall was initiated due to non-sterility concerns. FDA inspectors found insanitary conditions at the manufacturing facility and positive bacterial test results from environmental sampling. All lots of the product are affected.
Consumers who have purchased this product should stop using it immediately. Consumers with questions may contact Cardinal Health or consult with their healthcare provider regarding potential exposure.
The recalled product
- Product
- DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
- Brand
- DRY EYE RELIEF
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Ophthalmic
- Hazard
- non-sterile
- bacterial-contamination
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.
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