Drug recall: DRY EYE RELIEF eye drops for non-sterility
FDA recalls DRY EYE RELIEF eye drops nationwide due to non-sterility. The ophthalmic product distributed in 23,208 bottles affects all lots. Consumers should discontinue use immediately.
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: This is classified as an FDA Class I recall, which per the severity rubric is a criterion for Critical (score 5). Non-sterility in ophthalmic drugs represents a documented manufacturing defect with significant risk of serious ocular infection and sight-threatening complications.
Plain-English summary
The FDA is recalling DRY EYE RELIEF eye drops (Carboxymethylcellulose Sodium 1%) manufactured by Kilitch Healthcare India Limited and distributed by Cardinal Health. The recall affects 23,208 bottles of the 0.5 FL OZ (15 mL) product, with all lot numbers included. The product was distributed nationwide within the United States.
The recall was initiated due to non-sterility concerns. Non-sterile ophthalmic drugs can pose a risk of ocular infection and other eye complications.
Consumers who have purchased DRY EYE RELIEF eye drops should stop using the product immediately and either discard it or return it to the retailer. Anyone who has used this product and experiences eye discomfort, irritation, or signs of infection should consult a healthcare provider.
This is classified as an FDA Class I recall, the most serious classification level.
The recalled product
- Product
- DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
- Brand
- DRY EYE RELIEF
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Ophthalmic / Eye Drops
- Hazard
- Affected units
- 23,208
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 22 recalled by Kilitch Healthcare India Limited 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 22 products in this recall →Related recalls
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