Agency classClass IOur severity:Critical FDA (Drugs)·D-0299-2024·Announced 2024-02-14

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.

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: 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: non-sterility
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 →

Same brand · DRY EYE RELIEF

Severe
FDA Recalls Dry Eye Relief Drops Nationwide Due to Non-Sterility
FDA (Drugs) · 2024-02-14
Severe
Eye drops recalled for non-sterility due to bacterial contamination
FDA (Drugs) · 2023-11-29
Critical
FDA Recalls Non-Sterile Dry Eye Relief Drops Due to Bacterial Contamination
FDA (Drugs) · 2023-11-29

Same manufacturer · Kilitch Healthcare India Limited

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Critical
FDA Recalls CVS Health Lubricating Eye Drops Due to Non-Sterility
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Severe
Drug: Lubricant Eye Drops Recalled Nationwide Due to Non-Sterility
FDA (Drugs) · 2024-02-14
Severe
FDA recalls Leader brand Lubricant Eye Drops nationwide for non-sterility
FDA (Drugs) · 2024-02-14
Severe
FDA Recalls Non-Sterile Lubricant Eye Drops Due to Contamination Risk
FDA (Drugs) · 2024-02-14
Severe
Drug recall: Velocity Pharma Lubricating Eye Drops non-sterility risk
FDA (Drugs) · 2024-02-14

Same hazard · non sterility