Over 75,000 Units of Eye Drops Recalled Nationwide Over Sterility Concerns, FDA Confirms

By: Carl Schwartzbaum

If you regularly use eye drops to soothe dry or irritated eyes, NBC News reported on Tuesday that there’s an urgent recall you should be aware of. More than 75,000 units of various ophthalmic solutions are being voluntarily pulled from shelves across the United States due to concerns over sterility, according to an enforcement report issued by the U.S. Food and Drug Administration (FDA).

The recall, which was originally initiated by AvKare, a prominent medical and pharmaceutical manufacturer, follows an FDA inspection of BRS Analytical Service, a pharmaceutical testing laboratory involved in the quality assurance process for these products. The audit revealed a series of violations of the FDA’s Current Good Manufacturing Practice (cGMP) standards—critical regulatory protocols that ensure drugs and medical products are manufactured safely and consistently.

As the NBC News emphasized in its detailed report, the FDA concluded that the deviations from these standards left the sterility of the affected products in question, presenting a potential health risk to consumers. According to AvKare’s official recall announcement, “cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”

The affected products were distributed over a nearly two-year span, from May 26, 2023, through April 21, 2025. All are labeled as ophthalmic solutions designed to relieve symptoms of dry, itchy, or irritated eyes—often marketed under the generic term “artificial tears.” The specific items subject to the recall include:

NDC# 50268-043-15 – Artificial Tears Ophthalmic Solution

NDC# 50268-066-15 – Carboxymethylcellulose Sodium Ophthalmic Gel 1%

NDC# 50268-068-15 – Carboxymethylcellulose Sodium Ophthalmic Solution

NDC# 50268-126-15 – Lubricant Eye Drops Solution

NDC# 50268-678-15 – Polyvinyl Alcohol Ophthalmic Solution

According to the information provided in the NBC News report, these products may have reached pharmacies, hospitals, and retail outlets nationwide, making it essential for consumers to check any eye drop packaging they currently have on hand.

AvKare and the FDA are urging all consumers to immediately stop using the affected products. The report at NBC News outlined the process for returning recalled items and receiving a refund. Consumers should fill out a Recall Form and email it to AvKare. Upon receipt, AvKare will issue a Return Authorization Form, which must be included in the return package.

Returns should be sent to:

R&S Northeast LLC

8407 Austin Tracy Road

Fountain Run, KY 42133

The package should be clearly labeled: Ophthalmic RECALL. AvKare has committed to issuing full credit, including reimbursement of any shipping costs, upon receipt of the returned products.

This recall is a stark reminder of the importance of strict oversight and compliance in pharmaceutical manufacturing—particularly for products used on or near sensitive areas such as the eyes, as was pointed out in the NBC News report. Sterility in eye drops is crucial, as any contamination can result in serious infections or vision-threatening complications.

While no illnesses or injuries have yet been reported in connection to these specific products, the lack of assurance regarding their sterility elevates the potential for harm. In the wake of a similar recall earlier this year involving artificial tear products linked to rare bacterial infections, federal health officials are heightening their vigilance over eye care products.

If you are currently using one of the recalled products, it is recommended that you consult with a healthcare provider or pharmacist to identify safe and effective alternatives. Numerous over-the-counter brands have been vetted and approved by ophthalmologists and are available at most pharmacies.

As the NBC News report indicated, consumers should remain informed and proactive. Reviewing product labels, tracking lot numbers, and staying updated through official FDA announcements or media coverage can help minimize risks and ensure your health and safety when using over-the-counter eye care products.

For those affected by this recall, timely action is essential. Stopping use, reporting the product, and obtaining a suitable replacement are key steps in safeguarding eye health.