CLASS I ONGOING Drug recall · Reported 14 Feb 2024 · FDA Enforcement Report
Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%) recalled
Kilitch Healthcare India is recalling Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), distributed nationwide in the US. The recall was initiated on 13 Nov 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-0291-2024
- FDA event ID
- 93357
- Recalling firm
- Kilitch Healthcare India, Navi Mumbai
- Brand
- Lubricant Drops
- Manufacturer
- CARDINAL HEALTH 110, LLC. DBA LEADER
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Nov 2023
- FDA classified
- 5 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 13 Nov 2023 | Recall initiated by company | |
| 5 Feb 2024 | Classified by FDA | +84 days |
| 14 Feb 2024 | Published in enforcement report | +9 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
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%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Non-Sterility
Which lots are affected?
All lots
Where was it sold?
Nationwide within the United States
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.
Other products in this recall event
21 other products · FDA event 93357This product is part of a recall event; the main page for the event is Up&Up dry eye relief (Carboxymethylcellulose 0.5%) recalled.
More recalls from Kilitch Healthcare India
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Lubricant Eye Drops (Propylene glycol 0.6%) recalled | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Leader Dry Eye Relief (Polyethylene glycol recalledDry Eye Relief | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%) recalled | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Lubricant Gel Drops (Polyethylene glycol recalled | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops recalled | Kilitch Healthcare India | Sterility | Nationwide |
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, 0.5%) recalledLubricant Drops | Cardinal Health | Sterility | Nationwide |
| Drug | CLASS I | Leader Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) recalledDry Eye Relief | Cardinal Health | Sterility | Nationwide |