Elevated risk U.S. Food and Drug Administration

Systane Lubricant Eye Drugs recall: Due to Fungal Contamination

Recall published 1+ years ago

Due to Fungal Contamination

Systane Prescription & OTC drugs — recalled prescription & otc drugsSystane Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Systane Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

What the notice says: If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
December 21, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Systane
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
300651432060

Products covered by this recall

Lubricant Eye Drugs

What the company announced

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.

Risk Statement: Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients. To date, Alcon Laboratories has not received any reports of adverse events related to this recall.

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).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 300651432060

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25
  • 10101

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2025/09

NDC number

On the carton and again on the bottle or blister label.

  • 0065-1432-06

Package size

Match the net weight or the piece count on the front of the pack.

  • 25 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Systane — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Remedy named in the notice: 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.

Company contact: Alcon Laboratories — Consumers: Alcon Laboratories, 1-800-241-5999 — Media: Steven Smith, 213-280-9974, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Systane prescription & otc drugs recalled?

Due to Fungal Contamination If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 300651432060; lot code 25, 10101; best-by date 2025/09. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The notice says: 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.

Where was the recalled product sold?

It was distributed nationwide.

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