Eye care products are called back. The United States is recalling a number of eye care products in a broad consumer safety notice. After significant problems were found during a recent FDA inspection, BRS Analytical Service, LLC announced the recall. We’ll talk about the reasons behind the recall of eye care items today, as well as what you should do in the event of one.
Why This Recall Matters
The recall is being done at the consumer level, meaning it impacts day-to-day users. These are items that are typically used to treat dry eyes, irritation, and other day-to-day eye problems.
But the FDA audit found that the company did not adhere to current Good Manufacturing Practices (cGMP). These are critical guidelines ensuring the safety and quality of medicines. Non-compliance with these standards may lead to contamination, instability, or other problems that directly threaten user health.
What did the FDA find out about the use of cGMP?
According to the FDA audit released recently, BRS Analytical Services, LLC, has not manufactured its products using the cGMP protocols. This protocol says that the manufacturing units are permitted to use only a limited quantity of drugs in their medicines. However, BRS Analytical Services surely hasn’t followed these instructions for its own benefit.
It is not confirmed if the non-adherence to the quality standards set by the FDA poses health risks to consumers. However, it is certain that these standards are set to prevent any unwanted effects due to compromised quality. These products can also become the cause of many health-related risks, due to the overdose of drugs in the medicines. Therefore, the recall became a necessity, noting the current circumstances of potential risk to patients.
Additionally, this became the primary reason for announcing a recall of the eye care products manufactured by this company. The FDA has mentioned that these faulty eye care products pose a Class II risk level, which can affect health. These risks involve temporary medical issues, which can be cured by medicines, but can possibly disrupt your routine activities. Moreover, the probability of some serious effects on a patient’s health is very low, but it is possible.
Which Products Are Affected?
Some very common products are involved in the recall. Each of those was shipped throughout the U.S. from May 26, 2023, to April 21, 2025. The affected products are as follows:
- Artificial Tears Ophthalmic Solution (NDC# 50268-043-15)
- Carboxymethylcellulose Sodium Ophthalmic Gel 1% (NDC# 50268-066-15)
- Carboxymethylcellulose Sodium Ophthalmic Solution (NDC# 50268-068-15)
- Lubricant Eye Drops Solution (NDC# 50268-126-15)
- Polyvinyl Alcohol Ophthalmic Solution (NDC# 50268-678-15)
These eye drops and gels are often sold over-the-counter in pharmacies and used without medical supervision. That makes this recall even more critical.
What Should Consumers Do?
Stop using these products immediately. Discontinue use whether or not you’ve experienced symptoms. The manufacturer advises all customers to check the National Drug Code (NDC) numbers on their packaging.
If you possess the product, complete the “Quantity to Return” and Customer Information fields on the recall notice. Subsequently, send the completed form either by fax at 931-292-6229 or by e-mail at customerservice@avkare.com.
Even if you’ve dispossessed yourself of the product already, the company still asks that you report your purchase and return the recall notice form. It assists in tracking distribution and avoiding further danger.
What Are the Risks?
Although no certain health problems have yet been widely reported in association with these items, poor manufacturing is a number of issues. Eye care items, particularly sterilized ones, have to ensure high standards of safety. In the event of these standards being breached, the product can:
- Causes eye infection
- Result in blurred vision
- Cause irritation or allergic responses
- Possibly cause existing eye complaints to worsen
- This is especially risky to those with pre-existing sensitive eyes or weakened immunity.
Industry Responsibility
This recall is a harsh reminder of the importance of FDA compliance. The cGMP regulations exist not only to shield firms from legal issues but to safeguard consumers from injury. When a firm skimps on quality or misses tight controls, the consequences can be severe.
BRS Analytical Service, LLC’s voluntary decision to recall products is a welcome move. But now the concern has to lie with public education and prevention.
What’s Next?
In case you’ve had any undesirable reaction following use of these eye care products, report it at once to your healthcare provider. You can even lodge a complaint with the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Hence, be attentive and take necessary action to save your family and yourself from unhealthy foods.
What alternatives can be used instead of these overdosed drug products?
The above-the-counter eye drops, which contain the above-mentioned chemical properties, are hazardous to your health. However, there are always loopholes to cure the sudden itchiness and dryness in your precious eyes. These methods are generally safe and will not cost you anything than using your home material, like a soft cloth. Moreover, experts suggest that in case of dryness, always grab a soft cloth and give a warm compress to your eyes for 30 seconds. You can practice it daily, as taking care of your eye health is not something to be ashamed of.
If you are lazy enough to grab a cloth for yourself, Dr. Rapoport has mentioned a technological method for your dry, itchy eyes. Humidity is a useful component for your eyes, which helps them to maintain their moisture and liquid properties. Moreover, Dr. Yuna Rapoport has suggested that these patients can use a humidifier instead of eye drops to avoid consequences. This way, they can prevent the use of drug-based products, which can sooner or later affect their health.
Conclusion
All in all, consumer safety begins with awareness. If you or someone you know wears artificial tears or any type of over-the-counter eye drops, take a moment to double-check the label. A quick glance could save you from a severe health scare.
Stay alert, stay informed, and take care of your eyes.
