A sweeping recall of ophthalmic products has been issued across the United States, after federal regulators raised serious concerns about sterility violations that could pose health risks to millions of consumers. The U.S. Food and Drug Administration (FDA) confirmed that over 75,000 units of eye drops and artificial tear solutions are being pulled from pharmacies and healthcare providers following a compliance audit of the manufacturer.
The recall, officially announced on April 23, 2025, involves five specific eye care products manufactured by Tennessee-based BRS Analytical Service, LLC and distributed by AvKARE. The items were available nationwide through a wide network of retailers and healthcare channels between May 2023 and April 2025. Though no confirmed reports of injury have been linked to the recalled products so far, the FDA issued a Class II recall, indicating that use of these items could lead to temporary or medically reversible adverse effects if contaminated.
The products affected include:
- 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)
Each of these products is designed to provide moisture and relief for dry or irritated eyes. However, the FDA’s inspection revealed systemic failures in manufacturing practices—particularly regarding sterility assurance protocols, a critical factor in ophthalmic medications.
Regulators warn that compromised sterility in eye drops can result in irritation, inflammation, and in more serious cases, eye infections. Given that ophthalmic solutions are applied directly to one of the most sensitive organs in the human body, sterility standards are among the strictest in the pharmaceutical sector.
Consumers who have purchased any of the listed products are urged to stop using them immediately, check NDC numbers and lot codes, and contact AvKARE for instructions on disposal and refund processing. Healthcare providers have also been advised to cease distribution and quarantine any remaining inventory.
While no hospitalizations have been tied to this recall, experts stress that users with weakened immune systems or those recovering from ocular surgery should exercise additional caution.
This is not the first time concerns have emerged around mass-market eye care items. In October 2023, the FDA warned against the use of 26 over-the-counter eye drop products from multiple brands, citing contamination risks. In December 2024, Alcon Laboratories voluntarily recalled a batch of its Systane Ultra PF drops after fungal particles were detected during a quality assurance check.
The FDA continues to monitor the situation and has not ruled out further enforcement actions. Consumers and medical professionals are encouraged to report any suspected adverse effects to the agency’s MedWatch program to support ongoing investigations.
As of now, the FDA has not disclosed whether criminal or civil penalties will be pursued against the manufacturer. However, the agency emphasized the recall as part of its broader effort to restore public confidence in over-the-counter eye health products.
