Cardinal Health recalls LEADER Lubricant Eye Drops due to non-sterility found at manufacturing facility. Product may contain bacteria and cause eye infections.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Cardinal Health is recalling LEADER Lubricant Eye Drops because FDA testing found bacterial contamination at the manufacturing facility. Using these drops could lead to eye infections or other infections.
The product was made in a facility with insanitary conditions, leading to positive bacterial test results. This means the drops may contain harmful bacteria that can cause eye infections.
People who own or use LEADER Lubricant Eye Drops (2 bottles, 0.5 fl oz) are affected. Those with sensitive eyes or existing eye conditions may be at higher risk.
Check for LEADER brand Lubricant Eye Drops with 2 bottles, 0.5 fl oz (15 mL) dropper bottles. The product was distributed by Cardinal Health and made in India with NDC numbers 70000-0090-2 (carton) and 70000-0090-1 (bottle).
Look for the NDC numbers 70000-0090-2 (carton) and 70000-0090-1 (bottle) on the packaging.
FDA found insanitary conditions and positive bacterial test results at the manufacturing facility.
The recall record does not specify a remedy, so contact Cardinal Health for guidance.
The hazard is non-sterility, which may cause eye infections but does not typically lead to serious injury.
We’ve drafted a message you can send LEADER to request your refund or repair — edit it as you like.
Subject: Recall D-0134-2024 — LEADER LEADER Hello, I own a LEADER that is covered by recall D-0134-2024 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.