Systane Lubricant Eye Drops Recalled for Non-Sterility Risk
Alcon Research is voluntarily recalling Systane Lubricant Eye Drops, Ultra PF, due to non-sterility concerns. The recall affects 55,960 boxes distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for a non-sterile pharmaceutical eye drop product. While no illnesses or injuries have been reported, the Class I designation reflects serious potential for adverse health effects from microbial contamination.
Plain-English summary
Alcon Research LLC is recalling Systane Lubricant Eye Drops, Ultra PF (lot 10101, expiring September 30, 2025) due to non-sterility. The affected product consists of 25-count boxes containing 0.7 mL vials and has been distributed throughout the United States, with approximately 55,960 boxes involved in this recall.
Non-sterile eye drops may become contaminated with bacteria or other microorganisms during manufacturing or storage. The FDA has classified this as a Class I recall, indicating the potential for serious health consequences.
This is a voluntary recall initiated by the manufacturer. Consumers who have purchased the affected product should stop using it immediately and consult their healthcare provider or contact Alcon for guidance. The product should be properly disposed of.
The recalled product
- Product
- Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
- Manufacturer
- Alcon Research LLC
- Category
- Drug — Eye Drops
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 10101
- Exp.09/30/2025
Distribution
Distributed nationwide across the United States.
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