Multiple over-the-counter eye products are being recalled nationwide after an audit from the U.S. Food and Drug Administration revealed serious manufacturing violations that could potentially pose a health risk to consumers.
1.
BRS Analytical Services, LLC announced a voluntary consumer-level recall of several ophthalmic products due to current Good Manufacturing Practice (cGMP) deviations identified by the FDA.
Although the specific health risks have not been confirmed, the deviations could result in ‘unacceptable quality’ and pose potential safety concerns.
Several eye-care products have been recalled
The affected products 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)
2.
What are the potential risk factors for consumers?
These products were distributed between May 26, 2023, and April 21, 2025. Consumers are advised to stop using the affected items immediately and dispose of them properly.
According to Fox 8, no adverse events have been reported. However, experts warn that eye drops—particularly those for dryness or irritation—must adhere to strict sterility and formulation standards to prevent serious risks such as infections or vision loss.
Each product is associated with specific lot numbers and expiration dates. If you purchased any affected items, click here for full recall details.
