Urgent safety recall for eye care products
(WJW) - Multiple over-the-counter eye care products are being voluntarily recalled nationwide after a U.S. Food and Drug Administration audit revealed serious manufacturing violations.
BRS Analytical Service announced the consumer-level recall of five ophthalmic solutions due to violations of current good manufacturing practices. Though the specific health hazards remain undetermined, the deviations raise concerns that the products may not meet quality standards, making potential risks to patients impossible to rule out.
The recalled 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)
These items were distributed between May 26, 2023, and April 21, 2025. Click here for the full lot number list.
Consumers are urged to stop using these products immediately.
While there have been no confirmed adverse events linked to the products so far, experts caution that eye drops, especially those intended to treat dryness or irritation, must meet strict sterility and formulation standards to avoid serious complications such as eye infections or vision loss.
Customers are instructed to complete the “Quantity to Return” section on the recall notice and email it to customerservice@avkare.com or fax it to 931-292-6229, even if they no longer possess the product.