Cardinal Health recalls LEADER Dry Eye Relief (0.33 fl oz) due to non-sterility found at manufacturing facility. FDA detected bacterial contamination in environmental samples.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Cardinal Health is recalling LEADER Dry Eye Relief eye drops because the manufacturing facility had unsanitary conditions and bacterial contamination. This poses a risk of infection from using the product.
The FDA found bacterial contamination in the manufacturing facility's environment. This means the product may not be sterile and could cause eye infections if used.
People who own or use LEADER Dry Eye Relief eye drops with the specific 0.33 fl oz (10 mL) dropper bottle. Those with sensitive eyes or compromised immune systems may be at higher risk.
Check for LEADER brand Dry Eye Relief eye drops in 0.33 fl oz (10 mL) dropper bottles. The product was distributed by Cardinal Health in Dublin, Ohio and made in India. All lots are affected.
Look for the LEADER brand, 0.33 fl oz (10 mL) dropper bottle, and NDC 70000-0088-1 on the label.
The FDA found bacterial contamination in the manufacturing facility, so the product is not sterile and may cause eye infections. Do not use.
Check for LEADER brand Dry Eye Relief in 0.33 fl oz (10 mL) dropper bottles with NDC 70000-0088-1. All lots are affected.
The recall does not specify a remedy, so contact Cardinal Health for guidance on safe disposal or alternatives.
We’ve drafted a message you can send LEADER to request your refund or repair — edit it as you like.
Subject: Recall D-0135-2024 — LEADER LEADER Hello, I own a LEADER that is covered by recall D-0135-2024 from LEADER. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
