Systane Eye Drops (Mckesson) – Storage Deviation (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.
Brand
Mckesson Medical-Surgical Inc. Corporate Office
Lot Codes / Batch Numbers
Part# a) 0065042915, b) 0065042930
Products Sold
Part# a) 0065042915, b) 0065042930
Mckesson Medical-Surgical Inc. Corporate Office is recalling Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubrican due to CGMP Deviations: products were stored outside the drug label specifications.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: products were stored outside the drug label specifications.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026