5 Critical Facts About The Systane Eye Drops Recall (Lot 10101) You Must Know Now
The safety of your vision is paramount, and consumers of popular over-the-counter eye drops were recently put on high alert following a major product safety notice. As of today, December 22, 2025, the most significant and recent safety event concerning the Systane brand remains the voluntary nationwide recall issued by Alcon Laboratories in late December 2024. This action targeted a specific lot of their widely used lubricant eye drops, underscoring the critical importance of checking your medicine cabinet immediately for the affected product.
This comprehensive guide details the precise product, the dangerous reason behind the recall, the specific lot number you need to look for, and the immediate steps you must take to protect your eye health. The recall, prompted by a consumer complaint, serves as a stark reminder of the potential risks associated with contaminated ophthalmic products.
The Critical Details of the December 2024 Systane Recall (Lot 10101)
The voluntary recall, initiated by manufacturer Alcon Laboratories on December 21, 2024, and publicized by the U.S. Food and Drug Administration (FDA) shortly thereafter, was a targeted action, not a blanket recall of the entire Systane product line. It is essential for consumers to understand the exact product specifications to determine if they possess the contaminated drops.
Affected Product and Lot Identification
The recall was limited to a single lot of one specific product formulation. This precision is vital for consumer safety and avoids unnecessary panic regarding other Systane products.
- Product Name: Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go
- Packaging: 25-count carton of single-use, low-density polyethylene (LDPE) plastic vials
- Lot Number: 10101 (This is the single, critical identifier)
- Expiration Date: 2025/09 (September 2025)
- NDC (National Drug Code): 0065-1432-06
- UPC (Universal Product Code): 300651432060
The "PF" in the product name stands for Preservative-Free, a common choice for individuals with sensitive eyes, which makes the purity of the single-use vials even more critical. The recall was classified as a voluntary nationwide action, meaning the product was distributed across the United States.
The Dangerous Reason for the Recall: Fungal Contamination
The catalyst for the recall was a consumer complaint reporting the presence of "foreign material" inside a sealed, unused plastic unit dose vial. Subsequent testing confirmed this foreign material to be fungal in nature.
Fungal contamination in any ophthalmic solution is a severe health risk. Unlike an oral medication, eye drops are applied directly to the surface of the eye, which is a delicate and highly susceptible environment. The FDA and Alcon classified this as a necessary recall due to the potential for serious adverse health consequences.
Why Fungal Contamination in Eye Drops is a Major Health Risk
The risk associated with using a contaminated eye drop, particularly one containing fungal material, extends far beyond simple irritation. The eye's natural defenses, while robust, can be easily overwhelmed by direct application of a contaminated substance.
Potential Adverse Health Consequences
Using a contaminated eye drop can lead to a spectrum of ocular infections, ranging from mild to vision-threatening. The primary concerns associated with the Systane recall’s fungal contamination include:
- Severe Ocular Infections: Fungi can cause serious infections of the cornea (keratitis), which is the clear, dome-shaped outer layer of the eye.
- Vision Loss: Fungal keratitis is notoriously difficult to treat and can rapidly progress, potentially leading to permanent vision impairment or blindness if not treated aggressively and immediately.
- Systemic Infection: While less common, in immunocompromised patients, a severe ocular infection could theoretically lead to a systemic infection spreading beyond the eye.
- Inflammation and Pain: Even a non-infectious foreign body can cause severe inflammation, redness, and significant eye pain.
Alcon emphasized that while the risk of a serious adverse event is low, it is not zero. The voluntary recall was a precautionary measure to prevent any potential harm to consumers who rely on these drops for dry eye relief.
Immediate Steps for Consumers: How to Check Your Systane Drops
If you have purchased Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count, it is imperative that you check the lot number printed on the carton and the individual foil pouches.
Action Plan for Consumers with Lot 10101
Do Not Use: If your product matches the lot number 10101, stop using the eye drops immediately. Do not attempt to use any remaining vials from that package.
Check the Packaging: The lot number is typically printed on the bottom of the carton and may also be on the foil pouch containing the single-use vials. The expiration date should read 2025/09.
Return or Discard: The FDA advised distributors and retailers to discard any remaining stock of the affected lot. As a consumer, you should return the recalled product to the place of purchase for a refund or replacement, or contact Alcon directly for instructions on disposal and reimbursement.
Contact Information: For questions regarding the recall, consumers were directed to contact Alcon at 1-800-757-9195.
General Eye Drop Safety and Topical Authority
This recall highlights a crucial aspect of topical eye care: the sterility of the product. Preservative-free, single-use vials are generally considered safer for avoiding contamination during use, but manufacturing defects, as seen in this case, can still pose a risk.
Always check the following for any eye drop product:
- Expiration Date: Never use drops past their expiration date.
- Clarity: Before use, hold the vial up to the light. The liquid should be clear and free of any visible particles, cloudiness, or foreign material. If you see anything unusual, discard the product immediately.
- Tip Contact: Never let the tip of the eye drop bottle or vial touch your eye, eyelid, or any other surface, as this is the most common cause of self-contamination during use.
Alcon’s Response and Moving Forward
Alcon Laboratories issued the recall voluntarily and promptly followed the consumer complaint, demonstrating a commitment to patient safety and regulatory compliance. The company worked closely with the FDA to ensure the affected lot was removed from the market nationwide.
The contamination was isolated to Lot 10101, suggesting a specific issue during that particular manufacturing run, rather than a systemic problem with the entire Systane brand. Consumers can generally continue to use other Systane products, such as Systane Ultra, Systane Complete, or other lots of the Ultra PF, with confidence, provided they follow general safety guidelines and check for clarity before use.
The December 2024 Systane recall serves as a powerful reminder for all consumers to remain vigilant about over-the-counter ophthalmic products. By understanding the specific details of Lot 10101 and the potential risks of fungal contamination, you can take proactive steps to safeguard your vision and ensure the continued efficacy of your dry eye treatment.
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