Agency classClass IOur severity:Severe FDA (Drugs)·D-0295-2024·Announced 2024-02-14

FDA Recalls Dry Eye Relief Drops Nationwide Due to Non-Sterility

The FDA has issued a Class I recall of Dry Eye Relief eye drops sold nationwide due to non-sterility concerns. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary recall affecting 12,960 bottles.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recalls carry a minimum severity score of 4 per the rubric. Non-sterility in an ophthalmic product poses significant risk of contamination and serious eye infection.

Plain-English summary

Dry Eye Relief eye drops containing Polyethylene glycol 400 0.4% and Propylene glycol 0.3% are being recalled. The product is sold in 0.33 FL OZ (10 mL) bottles under the Leader brand and distributed by Cardinal Health (NDC 70000-0088-1) nationwide within the United States. The recall involves 12,960 bottles and affects all lots of the product.

The manufacturer, Kilitch Healthcare India Limited, initiated this voluntary recall beginning November 13, 2023, due to non-sterility. The FDA classified this as a Class I recall on February 5, 2024.

This recall affects all consumers who obtained the product nationwide within the United States.

The recalled product

Product: DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
Brand: DRY EYE RELIEF
Manufacturer: Kilitch Healthcare India Limited
Category: Drug — Ophthalmic / Eye Drops
Hazard: non-sterility
infection-risk
Affected units: 12,960

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

Critical
Drug recall: DRY EYE RELIEF eye drops for 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

See all →

Critical
FDA Recalls CVS Health Lubricating Eye Drops Due to Non-Sterility
FDA (Drugs) · 2024-02-14
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