CLASS I ONGOING Drug recall · Reported 29 Nov 2023 · FDA Enforcement Report
Leader Eye Irritation Relief (Polyvinyl alcohol recalled
Cardinal Health is recalling Leader Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline, 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-0131-2024
- FDA event ID
- 93346
- Recalling firm
- Cardinal Health, Dublin, OH
- 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
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 Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1
Where it was distributed
Nationwide in the USA
Questions about this recall
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.
Other products in this recall event
5 other products · FDA event 93346This product is part of a recall event; the main page for the event is Leader Dry Eye Relief (Polyethylene Glycol recalled by Cardinal Health.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Leader Dry Eye Relief (Polyethylene Glycol recalled by Cardinal HealthDry Eye Relief | Cardinal Health | Sterility | Nationwide | |
| CLASS I | Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) recalledLubricant Drops | Cardinal Health | Sterility | Nationwide | |
| CLASS I | Leader Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) recalledDry Eye Relief | Cardinal Health | Sterility | Nationwide | |
| CLASS I | Leader Lubricant Eye Drops (Propylene Glycol, 0.6%) recalled | Cardinal Health | Sterility | Nationwide | |
| CLASS I | Leader Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) recalledLubricant Drops | Cardinal Health | Sterility | Nationwide |
More recalls from Cardinal Health
All 315| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium | Cardinal Health | Packaging Defects | KS |
| Drug | CLASS II | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector recalledXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Xolair (omalizumab injection), 75 mg recalled by Cardinal HealthXolair | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Recombinate, [Antihemophilic Factor (Recombinant)] vials recalled | Cardinal Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Wegovy (semaglutide) injection recalled by Cardinal Health | Cardinal Health | Temperature Abuse | NC, SC, VA |
Other Polyvinyl Alcohol recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Polyvinyl Alcohol Ophthalmic Solution recalledPolyvinyl Alcohol | BRS Analytical Services | Sterility | Nationwide |
| Drug | CLASS III | Polyvinyl Alcohol Ophthalmic Solution recalled by AvKAREPolyvinyl Alcohol | AvKARE | Packaging Defects | Nationwide |
| Drug | CLASS I | Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief | Kilitch Healthcare India | Sterility | Nationwide |