CLASS I ONGOING Drug recall · Reported 29 Nov 2023 · FDA Enforcement Report
Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 5%) recalled
Cardinal Health is recalling Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 5%), distributed nationwide in the US. The recall was initiated on 31 Oct 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0133-2024
- FDA event ID
- 93346
- Recalling firm
- Cardinal Health, Dublin, OH
- Brand
- Lubricant Drops
- Manufacturer
- CARDINAL HEALTH 110, LLC. DBA LEADER
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 31 Oct 2023
- FDA classified
- 1 Dec 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 31 Oct 2023 | Recall initiated by company | |
| 29 Nov 2023 | Published in enforcement report | +29 days |
| 1 Dec 2023 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 5%) recalled?
Yes. Cardinal Health recalled Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 5%) on 31 Oct 2023. The recall is Class I and its status is Ongoing. Recall number D-0133-2024.
Why was it recalled?
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Which lots are affected?
ALL LOTS
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Carboxymethylcellulose recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium | BRS Analytical Services | Sterility | Nationwide |
| Drug | CLASS III | Carboxymethylcellulose Sodium Ophthalmic Solution recalled by AvKARECarboxymethylcellulose Sodium | AvKARE | Packaging Defects | Nationwide |
| Drug | CLASS I | Leader Dry Eye Relief (Carboxymethylcellulose Sodium 1%) recalledDry Eye Relief | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium 5%) recalledLubricant Drops | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Leader Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) recalledDry Eye Relief | Cardinal Health | Sterility | Nationwide |