Agency classClass IOur severity:Severe FDA (Drugs)·D-0300-2024·Announced 2024-02-14

Target Lubricant Eye Drops Recalled for Non-Sterility

Target brand High Performance Lubricant Eye Drops have been recalled nationwide due to non-sterility. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary FDA Class I recall affecting 401,568 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: This is an FDA Class I recall, which requires a minimum severity score of 4. While no deaths or reported illnesses are mentioned in the source, non-sterility in eye drops presents a significant risk of infection.

Plain-English summary

Target brand High Performance Lubricant Eye Drops in 0.5 FL OZ (15 mL) bottles are being recalled. The affected products include both single pack (NDC 11673-522-15) and twin pack (NDC 11673-522-30) configurations. All lots are subject to the recall, affecting 401,568 bottles total.

The reason for the recall is non-sterility. Manufacturer Kilitch Healthcare India Limited voluntarily initiated this FDA Class I recall on November 13, 2023. The product was distributed nationwide within the United States by Target Corporation, Minneapolis, MN 55403.

The recall remains ongoing.

The recalled product

Product: Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis…
Manufacturer: Kilitch Healthcare India Limited
Category: Drug — Lubricant Eye Drops
Hazard: non-sterility
microbial-contamination
Affected units: 401,568

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 manufacturer · Kilitch Healthcare India Limited

See all →

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