Recall archive / FDA company announcement
Systane: Lubricant Eye Drugs — FDA announcement Dec 23, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Dec 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Lubricant Eye Drugs
- Reason
- Due to Fungal Contamination
- Classification
- Not supplied
- Recalling firm
- Alcon Laboratories
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 7f616019ff97029c
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | FOR IMMEDIATE RELEASE – 12/21/2024 – Fort Worth, Texas. Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the consumer level. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined the material to be fungal in nature.; Systane Lubricant Eye Drops Ultra PF is used for the temporary relief of burning and irritation in persons experiencing dry eye symptoms and is packaged in a cardboard carton containing 25 sterile, single-use LDPE plastic vials of preservative free solution for ophthalmic use (NDC 0065-1432-06, UPC 300651432060). The affected Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count is limited to lot number 10101, expiration date 2025/09. The product can be identified by the green and pink carton design, presence of “Systane” and “ULTRA PF” brand names on the front of the carton, and the “25 vials” package size. Please see product images included in this release. Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) was distributed nationwide to retail and internet outlets.; Consumers that have the recalled Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) which is being recalled should stop using them immediately and return to the place of purchase for a replacement or refund. Consumers with questions regarding this recall can contact Alcon Laboratories at 1-800-241-5999 between 7:30am and 6:00pm (Central), Monday to Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.; Alcon Laboratories is notifying its distributors and customers by letter, email, and/or phone call and is arranging for replacement of all recalled products. Distributors or retailers should discard any remaining stock of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101). |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Dec 23, 2024
- Company announcement date
- Dec 21, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.