The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0301-2024·Announced 2024-02-14

FDA recalls Leader brand Lubricant Eye Drops nationwide for non-sterility

Leader brand Lubricant Eye Drops (0.6% Propylene glycol) are recalled nationwide due to non-sterility concerns. 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 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: The FDA classified this as a Class I recall. Per the severity rubric, Class I drug recalls carry a minimum severity level of 4 (Severe). No deaths, serious injuries, or hospitalizations are reported in the source text.

Plain-English summary

Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%) are subject to a Class I recall. The product, manufactured by Kilitch Healthcare India Limited and distributed by Cardinal Health in Dublin, Ohio, was available nationwide in 0.33 FL OZ (10 mL) bottles with NDC 70000-0587-1. Approximately 14,784 bottles with all lot numbers are affected.

The recall was initiated on November 13, 2023, due to non-sterility. Eye drops applied directly to the eye must be sterile to prevent contamination-related safety concerns.

Consumers with this product should discontinue use immediately. Those with questions should contact the manufacturer or the FDA.

The recalled product

Product
Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1
Manufacturer
Kilitch Healthcare India Limited
Category
Drug — Ophthalmic / Eye Drops
Hazard
Affected units
14,784

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 →

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