Agency classClass IOur severity:Severe FDA (Drugs)·D-0291-2024·Announced 2024-02-14

FDA Recalls Non-Sterile Lubricant Eye Drops Due to Contamination Risk

The FDA recalled approximately 210,192 bottles of Leader brand Lubricant Eye Drops due to non-sterility that could allow contamination. All lots distributed nationwide are affected.

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 classification for drugs requires a minimum severity of Severe (4). No hospitalizations, serious injuries, or deaths have been reported. The hazard is potential contamination from non-sterility affecting an ophthalmic product.

Plain-English summary

The FDA has issued a Class I recall of Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), manufactured by Kilitch Healthcare India Limited. The affected product was distributed nationwide in approximately 210,192 bottles in two package formats: single packs and twin packs (NDC 70000-0090-1 and 70000-0090-2).

The recall was issued because the product failed to meet sterility requirements. Non-sterile eye drops can become contaminated with harmful microorganisms that may cause eye infections or other complications.

Cardinal Health (Dublin, Ohio) distributed the product under the Leader brand. This voluntary recall was initiated by the manufacturer starting November 13, 2023.

Consumers should stop using this product immediately. Anyone who has experienced eye symptoms such as redness, pain, irritation, or discharge after using the product should consult a healthcare provider.

The recalled product

Product: LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
Brand: LUBRICANT DROPS
Manufacturer: Kilitch Healthcare India Limited
Category: Drug — Eye Drops
Hazard: non-sterile
Affected units: 210,192

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 · LUBRICANT DROPS

Severe
FDA Recalls LEADER Brand Lubricant Eye Drops Due to Non-Sterility Risk
FDA (Drugs) · 2023-11-29
Severe
LEADER Lubricant Eye Drops Recalled Nationwide for Non-Sterility Concerns
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
Drug recall: Velocity Pharma Lubricating Eye Drops non-sterility risk
FDA (Drugs) · 2024-02-14
Severe
Drug Recall: Non-Sterile Lubricant Eye Drops Distributed Nationwide
FDA (Drugs) · 2024-02-14

Same hazard · non sterile