CLASS II ONGOING Drug recall · Reported 14 Oct 2026 · FDA Enforcement Report
Sterile High Performance Ultra Lubricating Eye Drops recalled
K.C. Pharmaceuticals is recalling Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4%, distributed nationwide in the US. The recall was initiated on 11 Sep 2026 and the FDA has classified it as Class II.
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-0009-2027
- FDA event ID
- 99880
- Recalling firm
- K.C. Pharmaceuticals, Pomona, CA
- Manufacturer
- Cardinal Health
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2026
- FDA classified
- 5 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 11 Sep 2026 | Recall initiated by company | |
| 5 Oct 2026 | Classified by FDA | +24 days |
| 14 Oct 2026 | 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
Lack of Assurance of 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
Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4% Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 1429905619 0; c) Good Sense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, NDC 50804-160-01; d) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20167 2.
Where it was distributed
US Nationwide
Stores named: Walgreens
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot: a) SU25B01, Exp.: 02/28/2027; b) SU25N01, Exp.: 11/30/2027; c) SU25B01, Exp.: 02/28/2027; SU25N01, Exp.: 11/30/2027; SU25N02, Exp.: 11/30/2027; d) SU25B01, Exp.: 02/28/2027.
Where was it sold?
US Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 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
7 other products · FDA event 99880This product is part of a recall event; the main page for the event is Sterile Lubricant Dry Eye Relief Eye Drops recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sterile Lubricant Dry Eye Relief Eye Drops recalledLeader Dry Eye Relief Eye Drops | K.C. Pharmaceuticals | Sterility | Nationwide | |
| CLASS II | Sterile EYE Drops Advanced Relief, (dextran recalledLeader Advanced Relief Eye Drops | K.C. Pharmaceuticals | Sterility | Nationwide | |
| CLASS II | Sterile Eye Drops, Original recalled by K.C. PharmaceuticalsGoodsense Eye Drops Original Formula | K.C. Pharmaceuticals | Sterility | Nationwide | |
| CLASS II | Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye | K.C. Pharmaceuticals | Sterility | Nationwide | |
| CLASS II | Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml | K.C. Pharmaceuticals | Sterility | Nationwide | |
| CLASS II | Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief | K.C. Pharmaceuticals | Sterility | Nationwide | |
| CLASS II | Sterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
More recalls from K.C. Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Eye Drops Redness Relief (Glycerin recalledLeader Eye Drops Redness Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile EYE Drops AC (tetrahydrozoline HCl recalledGoodsense Eye Drops Irritation Relief | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Eye Drops Maximum, Redness Relief, Sterile recalledTarget Eye Drops Maximum Redness Relief Eye | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Sterile Eye Drops, Original recalled by K.C. PharmaceuticalsGoodsense Eye Drops Original Formula | K.C. Pharmaceuticals | Sterility | Nationwide |
Other Polyethylene Glycol 400 recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ultra Lubricating Eye Drops (polyethylene recalledLeader Ultra Lubricating Eye Drops | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Lubricant Eye Drops Solution recalled by BRS Analytical ServicesLubricant Eye Drops Solution | BRS Analytical Services | Sterility | Nationwide |
| Drug | CLASS II | Systane, Lubricant Eye Drops recalled by Mckesson Medical-SurgicalSystane Lubricant | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |