Current Status of Xiidra and Product Safety
Prescription medication Xiidra (lifitegrast ophthalmic solution) has not been subject to a recall in October 2025 or in recent years. Any public confusion likely arises from unrelated recalls involving a broad range of over-the-counter (OTC) eye lubricants. For example, in May 2025, AvKARE and BRS Analytical Services initiated a nationwide recall of various eye care products due to manufacturing concerns and lack of sterility assurance. These issues, which affected products like Artificial Tears Ophthalmic Solution, are distinct from the regulated manufacturing and distribution of the prescription drug Xiidra.
The Change of Ownership and Continued Oversight
Xiidra has undergone significant corporate changes, but regulatory oversight has remained consistent. In 2023, Novartis divested its 'front of eye' ophthalmology assets, including Xiidra, to Bausch + Lomb. The sale was finalized in September 2023, and Bausch + Lomb took over the manufacturing and distribution of the product. Such ownership transfers are common in the pharmaceutical industry and do not inherently signal a problem with a drug. Bausch + Lomb, a leading eye health company, continues to market and manage Xiidra, adhering to all U.S. Food and Drug Administration (FDA) regulations.
Xiidra's History: An Important Distinction from Other Eye Drop Recalls
It is crucial to distinguish between prescription medications and non-prescription products when assessing recall information. In the past, specifically around June 2022, Novartis did issue a recall for certain lots of Xiidra due to potential impurities, before the acquisition by Bausch + Lomb. This was a controlled recall and affected specific batch numbers. Subsequent events, such as the numerous OTC eye drop recalls in 2023 and 2025 due to sterility issues, are completely separate events. This history highlights the importance of checking reliable sources, such as the FDA and the manufacturer, for precise information regarding any medication. The current status of the market, which has seen numerous non-prescription eye drop recalls, has led to a great deal of public anxiety and misinterpretation regarding the status of prescription eye treatments like Xiidra.
How to Identify a Recalled Product vs. Xiidra
- Check the NDC Code: National Drug Code (NDC) numbers are unique identifiers. Recalled products are always identified by their NDC, and it is a reliable way to check if your product is affected.
- Review Recalled Brand Names: Recalls are linked to specific brands. For instance, the May 2025 recall included several products distributed by AvKARE and was not associated with Xiidra.
- Consult FDA Enforcement Reports: The FDA website provides public access to all drug recall information, categorizing them by severity.
Common Side Effects of Xiidra
While not related to any recent recall, it is important to be aware of the common side effects of Xiidra:
- Eye irritation or discomfort during application
- Dysgeusia (an unusual taste sensation)
- Blurred vision
- Headache
These side effects are typically transient and mild. Any severe or persistent symptoms should be discussed with a healthcare provider immediately.
Comparison: Xiidra vs. Recalled Over-the-Counter Eye Drops
| Feature | Xiidra (Prescription) | Recalled OTC Eye Drops (e.g., AvKARE) |
|---|---|---|
| Active Ingredient | Lifitegrast | Varies (e.g., Artificial Tears, Lubricant) |
| Primary Use | Treatment for dry eye disease by addressing inflammation | Symptomatic relief for dry/irritated eyes |
| Recall Status | No active recall as of October 2025 | Several nationwide recalls issued in 2023 and 2025 due to potential contamination and sterility concerns |
| Reason for Recall | (Previous) Impurities in specific lots | (Recent) Lack of assurance of sterility and manufacturing issues |
| Manufacturer | Bausch + Lomb (formerly Novartis) | Varies (e.g., BRS Analytical Service, AvKARE) |
| Availability | Prescription only | Over-the-counter |
The Role of FDA Audits and Manufacturer Responsibility
The pharmaceutical supply chain is subject to rigorous regulatory oversight from agencies like the FDA. The recent eye drop recalls, while causing public concern, demonstrate this system at work. FDA audits can uncover manufacturing deviations, as was the case with the May 2025 recalls of AvKARE products. The voluntary nature of many recalls also shows a manufacturer's responsibility to act quickly when potential risks are identified. In Xiidra's history, the 2022 Novartis recall of specific lots was another example of a company and the FDA addressing a manufacturing issue proactively.
How to Stay Informed and Ensure Safety
To avoid confusion and ensure you are using a safe product, follow these steps:
- Verify Your Product: Confirm that the product you are using is, in fact, Xiidra and not an OTC product. Xiidra is a prescription-only drug.
- Check the Manufacturer: Your Xiidra is now produced by Bausch + Lomb. All recent recalls for other eye drops involve different companies.
- Consult Official Sources: For the most accurate and up-to-date recall information, always check the FDA website or the manufacturer's official announcements.
Conclusion: No Current Xiidra Recall
There is no current recall for the prescription medication Xiidra as of October 2025. The confusion has likely been driven by widespread news reports covering unrelated recalls of over-the-counter eye drop products. Past issues with specific Xiidra lots were resolved by Novartis before the company sold the product to Bausch + Lomb in 2023. Consumers should feel confident in the safety and ongoing availability of their prescribed Xiidra, but should always consult with their healthcare provider regarding any medication concerns.
For more information on prescription medications, you can visit the FDA's official website and search their database for drug recalls.
