Polyethylene Glycol 400 recalls
The FDA has published 3 recalls involving Polyethylene Glycol 400 since 2022. The latest was reported on 8 Apr 2026. Most were for sterility. K.C. Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls3since 2022
Last 12 months1reported
Class I00% of total
Ongoing2latest 8 Apr 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why polyethylene glycol 400 is recalled
Companies
Brands
By year
Ongoing polyethylene glycol 400 recalls
2 active| 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 |
All polyethylene glycol 400 recalls, newest first
3 total| 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 |
Should you stop taking Polyethylene Glycol 400?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.