In May 2025, the pharmaceutical industry faced yet another setback in the realm of eye care safety when BRS Analytical Service, LLC, initiated a widespread voluntary recall of several ophthalmic products. This BRS Analytical Service ophthalmic products recall affected over 75,000 cases of commonly used eye drops and gels, distributed nationwide through medical supplier AvKARE. The action was prompted by findings from a U.S. Food and Drug Administration (FDA) audit, which uncovered deviations from Current Good Manufacturing Practice (cGMP) regulations, including concerns over sterility assurance. As of January 2026, this recall remains a pertinent reminder of the vulnerabilities in over-the-counter (OTC) eye care manufacturing, especially following a series of similar incidents in recent years.
The BRS Analytical Service ophthalmic products recall has raised alarms among consumers who rely on these solutions for relief from dry eyes, irritation, and other common ocular issues. With products shipped from May 2023 to April 2025, the recall’s scope is extensive, impacting potentially millions of users. This article delves into the details of the recall, exploring the companies involved, the specific products affected, the underlying reasons, potential health implications, and steps for affected consumers. By understanding this event, we can better appreciate the importance of regulatory oversight in ensuring product safety and the ongoing challenges in the ophthalmic sector.
Background on BRS Analytical Service and AvKARE
BRS Analytical Service, LLC, based in St. Louis, Missouri, operates as an independent contract testing laboratory specializing in pharmaceutical analysis. Founded to provide quality control and testing services for drug manufacturers, the company has been involved in ensuring compliance with industry standards for various products, including ophthalmics. However, in this instance, BRS Analytical Service found itself at the center of the recall, not just as a tester but as the initiator due to manufacturing ties. Their website, archived as of February 2025, highlighted services like stability testing and microbial analysis, but by May 2025, it was no longer active, possibly reflecting the fallout from the FDA’s scrutiny.
AvKARE, headquartered in Pulaski, Tennessee, serves as the distributor for these products. As a veteran-owned business, AvKARE focuses on supplying pharmaceuticals to government entities, hospitals, and retail pharmacies. They partner with various manufacturers and labs, including BRS, to bring affordable generic and OTC medications to market. In the context of the BRS Analytical Service ophthalmic products recall, AvKARE handled the logistics of notification and returns, emphasizing their role in the supply chain. This partnership underscores how interconnected the pharmaceutical ecosystem is, where testing labs like BRS can influence product quality directly.
The recall echoes previous eye care crises, such as the 2022-2023 Pseudomonas aeruginosa outbreak linked to contaminated eye drops, which resulted in infections, vision loss, and even deaths. That event involved multiple brands and highlighted global manufacturing issues, particularly in facilities overseas. While the BRS Analytical Service ophthalmic products recall is domestic in origin, it shares themes of inadequate sterility controls, reminding us that even U.S.-based operations are not immune to lapses.
Details of the Recalled Products
The BRS Analytical Service ophthalmic products recall targets five specific OTC eye care items, all designed to lubricate and soothe the eyes. These products were marketed under generic labels and sold through various channels, including online retailers and pharmacies. Below is a comprehensive list of the affected products, including their National Drug Code (NDC) numbers, which are essential for identification:
| Product Name | NDC Number | Description |
|---|---|---|
| Artificial Tears Ophthalmic Solution | 50268-043-15 | Used for temporary relief of burning and irritation due to dryness of the eye. |
| Carboxymethylcellulose Sodium Ophthalmic Gel 1% | 50268-066-15 | A thicker gel formulation for longer-lasting lubrication, ideal for severe dry eye. |
| Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% | 50268-068-15 | A liquid solution for mild to moderate dry eye symptoms. |
| Lubricant Eye Drops Solution | 50268-126-15 | General-purpose drops for everyday eye comfort. |
| Polyvinyl Alcohol Ophthalmic Solution | 50268-678-15 | Provides a protective film over the eye surface to retain moisture. |
Each product has multiple lot numbers associated with it, spanning various expiration dates from 2025 to 2027. For instance, the Artificial Tears solution includes lots like 0126 (expiring October 26, 2025) up to 0199 (October 30, 2026). The Carboxymethylcellulose Sodium Gel has fewer lots, such as 0114 (September 4, 2025) and 0207 (December 5, 2026). The Solution 0.5% variant has an extensive list, including 0103 (April 26, 2025) through 0224 (March 27, 2027). Lubricant Eye Drops cover lots like 0117 (September 20, 2025) to 0222 (March 5, 2027), while Polyvinyl Alcohol includes 0120 (October 2, 2025) to 0179 (August 5, 2026).
These lots were distributed across the United States, with a total of approximately 13,872 cases of Artificial Tears, 1,610 of the Gel, 32,876 of the Solution 0.5%, 13,104 of Lubricant Drops, and 14,333 of Polyvinyl Alcohol—summing to over 75,000 cases. Consumers can check product packaging for these details to determine if their items are affected.
Reasons for the Recall
The core trigger for the BRS Analytical Service ophthalmic products recall was an FDA audit conducted prior to May 2025, which identified significant deviations from cGMP regulations. cGMP are FDA-enforced standards that govern the design, monitoring, and control of manufacturing processes to ensure product consistency, safety, and efficacy. Violations can include inadequate facility maintenance, improper equipment sterilization, or flawed quality control testing.
Specifically, the audit revealed a “lack of assurance of sterility,” meaning there was insufficient evidence that the products were free from microbial contamination during production. This is particularly critical for ophthalmic products, as the eye is highly susceptible to infections. Unlike oral medications, eye drops bypass many bodily defenses, making sterility paramount. BRS Analytical Service, as the testing entity, likely uncovered or was implicated in these lapses, leading to the voluntary recall to prevent potential harm.
This isn’t an isolated issue; the FDA has ramped up inspections post the 2023 eye drop outbreaks, where similar cGMP failures led to bacterial contaminations. In those cases, Pseudomonas aeruginosa caused severe outcomes, including enucleations (eye removals). While no specific pathogen was identified in the BRS case, the precautionary recall reflects a proactive stance to avoid escalation.
Potential Health Risks and Impacts
Although the health hazards associated with the recalled products are described as “unknown,” the FDA classified the recall primarily as Class II. This level indicates that use may cause temporary or medically reversible adverse health consequences, with a remote probability of serious issues. However, one report suggested a Class I classification, which denotes a reasonable probability of serious adverse events or death, though this appears inconsistent with the majority of sources.
Potential risks stem from non-sterile products, which could introduce bacteria, fungi, or particulates into the eye, leading to infections like conjunctivitis, keratitis, or worse. For vulnerable populations—such as the elderly, immunocompromised individuals, or contact lens wearers—these risks are amplified. No adverse events were reported at the time of the recall, but the extensive distribution period means latent issues could still emerge.
The economic impact is notable, with AvKARE offering full credits and shipping reimbursements, potentially costing thousands. Broader industry repercussions include heightened consumer distrust in generic eye care, prompting shifts toward branded alternatives.
Consumer Guidance and Next Steps
If you possess any products from the BRS Analytical Service ophthalmic products recall, immediate action is advised: discontinue use and quarantine the items. To initiate a return, download the recall notice from AvKARE’s website, complete the quantity and customer information sections, and submit via email to customerservice@avkare.com or fax to 931-292-6229—even if you have no product to return. AvKARE will then provide a Return Authorization Form for shipping the products back to their designated facility in Kentucky.
For questions, contact AvKARE directly. In case of any eye symptoms post-use, consult a healthcare professional promptly. To prevent future risks, always check FDA recall alerts and opt for products from reputable manufacturers with transparent supply chains.
Broader Implications for Eye Care Safety
This recall highlights systemic challenges in the ophthalmic industry, where cost-cutting in manufacturing can compromise safety. Following the 2023 outbreaks, the FDA has advocated for stricter import controls and domestic production standards. Consumers are increasingly turning to preservative-free options or single-use vials to minimize contamination risks.
Education plays a key role: proper storage (away from heat and light), avoiding tip contact with surfaces, and adhering to expiration dates can mitigate issues. Advocacy groups like the American Optometric Association urge regular eye exams and vigilance in product selection.
Conclusion
The BRS Analytical Service ophthalmic products recall serves as a cautionary tale in pharmaceutical accountability. By addressing cGMP deviations swiftly, BRS and AvKARE mitigated potential disasters, but this underscores the need for robust quality assurance. As we move forward in 2026, staying informed empowers consumers to protect their vision effectively.
FAQ: BRS Analytical Service Ophthalmic Products Recall
Q1: What products are included in the BRS Analytical Service ophthalmic products recall? A1: The recall affects five products: Artificial Tears Ophthalmic Solution (NDC 50268-043-15), Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC 50268-066-15), Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (NDC 50268-068-15), Lubricant Eye Drops Solution (NDC 50268-126-15), and Polyvinyl Alcohol Ophthalmic Solution (NDC 50268-678-15). Check lot numbers on packaging for specifics.
Q2: Why was the recall initiated? A2: An FDA audit found deviations from cGMP regulations and a lack of sterility assurance, potentially leading to products of unacceptable quality.
Q3: What should I do if I have these products? A3: Stop using them immediately, complete AvKARE’s recall form, and return for full credit. Contact customerservice@avkare.com for assistance.
Q4: Are there reported health issues from these products? A4: No adverse events were reported at the time of recall, but potential risks include eye infections due to sterility concerns.
Q5: How can I prevent similar issues in the future? A5: Monitor FDA recall alerts, choose preservative-free options, and consult eye care professionals for recommendations.
