Alcon Laboratories Recalls Systane Eye Drops Nationwide Over Fungal Contamination Risk

Alcon has not received any reports of adverse events related to this recall. However, the company is acting cautiously to ensure consumer safety.

On Dec. 21, Alcon Laboratories issued a voluntary recall of one lot of its Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25-count (Lot 10101) after a consumer complaint revealed the presence of foreign material later identified as fungal.

The recalled product, commonly used to temporarily relieve dry eye symptoms, poses a significant health risk if contaminated. Fungal contamination in ophthalmic products can cause serious eye infections, which may lead to vision loss. The infections could become life-threatening in sporadic cases, particularly in immunocompromised individuals.

Alcon has not received any reports of adverse events related to this recall. However, the company is acting cautiously to ensure consumer safety.

Recalled Product Details

The recall is limited to Lot 10101, which expires in September 2025. The product is packaged in cardboard cartons containing 25 single-use, preservative-free LDPE plastic vials. It can be identified by the green and pink carton design, the “Systane” and “Ultra PF” branding on the front, and the “25 vials” package size.

The affected lot was distributed nationwide to retail and online outlets, so consumers must check their purchased products.

What Consumers Should Do

Consumers who own the recalled product should stop using it immediately and return it to the place of purchase for a refund or replacement.

If you have questions or concerns, Alcon Laboratories’ Consumer Relations team can be reached at 1-800-241-5999, Monday through Friday, 7:30 a.m. to 6:00 p.m. CST. Consumers experiencing adverse effects or issues related to this product should consult their healthcare provider immediately.

Distributor and Retailer Actions

Alcon notified distributors and retailers directly by letter, email, or phone. To prevent further distribution, they were instructed to discard any remaining stock of the affected batch.

FDA Notification and Adverse Event Reporting

The U.S. Food and Drug Administration (FDA) has been informed of this recall. Consumers or healthcare providers who experience adverse reactions or quality problems related to the product are encouraged to report them to the FDA’s MedWatch Adverse Event Reporting program.

Reports can be submitted online, or forms can be requested via phone at 1-800-332-1088. Completed forms can be mailed to the address provided on the form or faxed to 1-800-FDA-0178.

Commitment to Safety

Alcon Laboratories emphasizes its commitment to consumer safety and product quality. In a statement, the company assured that it is working diligently to ensure all affected products are removed from circulation and replaced.

This recall highlights the importance of vigilance in product safety, especially for medical products intended for sensitive areas like the eyes. Consumers are urged to take immediate action if they possess the recalled lot, to prevent potential health risks.