Urgent Nationwide Recall of Popular Eye Care Product Issued by Federal Regulators
A sealed vial of Systane Lubricant Eye Drops containing fungal material triggered a nationwide recall on December 25, 2024. Alcon Laboratories pulled its single-use eye drops from stores after laboratory tests confirmed contamination in lot 10101. The Texas manufacturer ordered retailers to remove the product while establishing a consumer return program. Though no infections have been reported, the FDA warns that fungal contamination could damage vision.
5 Key Points
- Laboratory tests confirmed fungal contamination in sealed Systane vials on December 25, 2024.
- The recall covers lot 10101 of Systane Lubricant Eye Drops Ultra PF, expiring September 2025.
- Consumers must return affected products for refunds or replacements.
- FDA warns of potential vision damage from fungal eye infections.
- Retailers received orders to remove and destroy the remaining inventory.
Immediate Health Alert and Product Details
Alcon Laboratories halted Systane Lubricant Eye Drops Ultra PF distribution after confirming fungal growth in sealed product vials. The recalled drops belong to lot 10101, expiring in September 2025, packaged in green and pink cartons marked with “Systane” and “ULTRA PF” branding. Testing revealed fungal material in an unopened vial reported by a consumer, prompting the FDA’s December 25 safety notice. The manufacturer deployed teams to contact stores and online sellers nationwide, coordinating the removal of affected inventory through retail and internet outlets. The company initiated a three-pronged communication strategy, sending certified letters to distributors, following up with direct email notifications, and establishing dedicated phone lines for inventory tracking. Alcon’s customer service department now handles product returns and replacement requests, offering consumers refund and exchange options for affected units. The Texas-based manufacturer emphasized the importance of checking lot numbers, as this recall specifically targets the 25-count single-use vial packages.
Critical Safety Concerns and FDA Response
The Food and Drug Administration launched its safety investigation after receiving documentation of foreign material discovered in a sealed Systane vial. Laboratory analysis confirmed the fungal nature of the contamination, triggering the agency’s consumer protection protocols. The FDA’s December 25 alert warned that ‘Eye infections from contaminated drops may threaten vision, ‘detailing specific risks for different patient populations. The agency’s warning highlighted particular dangers for patients with compromised immune systems, noting that infections could spread beyond the eye and create life-threatening complications in severe cases. While Alcon reported no infections as of December 25, 2024, the voluntary recall aims to prevent potential complications. FDA inspectors continue examining the manufacturing facility’s sterility protocols to determine how fungal material entered sealed vials. The agency directed retailers to immediately quarantine the remaining inventory of lot 10101 and initiate destruction procedures according to federal guidelines.
Industry-Wide Quality Control Challenges
The Systane recall marks the latest in a series of eye product safety alerts that shaped pharmaceutical oversight throughout 2024. CVS and Walmart removed multiple eye ointment brands from shelves in February after FDA inspectors discovered sterility failures at their production facility. That recall affected Equate, CVS Health, and AACE Pharmaceuticals brands, expiring between February 2024 and September 2025, leading to nationwide product removals from both retail chains. The FDA identified a “lack of sterility assurance” at the manufacturing facility, prompting a comprehensive review of production practices. Before these events, Kilitch Healthcare India Limited faced similar contamination issues in November 2023, pulling 27 eye drop products from distribution after bacterial testing revealed safety concerns. The FDA maintains an active monitoring program for ophthalmic products, tracking potentially contaminated items through regular facility inspections and consumer reports. The agency’s rolling list of affected products helps healthcare providers and consumers identify potentially dangerous eye care items. At the same time, manufacturers work to strengthen quality control measures across the pharmaceutical industry’s ophthalmic sector.
FAQ
Q: How do I know if my eye drops are recalled?
A: Check for lot 10101, which expires in 2025/09, on Systane Lubricant Eye Drops Ultra PF 25-count packages.
Q: What should I do with recalled eye drops?
A: Stop using them and return them to your purchase location for a refund or replacement.
Q: Can contaminated eye drops cause permanent damage?
A: Yes, fungal eye infections may lead to vision loss, with greater risks for immunocompromised patients.
Q: Have these eye drops infected anyone?
A: No infections were reported to Alcon Laboratories as of December 25, 2024.
Q: Where were the recalled eye drops sold?
A: The affected lot was distributed nationwide to retail stores and online sellers.
Citations
Price, Stepheny (December 25, 2024). Potential ‘fungal contamination’ leads to nationwide recall of popular brand of eye drops: FDA. Fox Business. https://www.foxbusiness.com/healthcare/potential-fungal-contamination-leads-nationwide-recall-popular-brand-eye-drops-fda
