(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.

Medical distributor AvKARE said in a recent notice that BRS Analytical Service, LLC announced the consumer-level recall of five ophthalmic solutions due to violations of current manufacturing practices.

St. Louis-based BRS Analytical Service is an independent contract testing laboratory.

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 insert that accompanies the product states: “Most OTC (over the counter) drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.”

A label from AvKARE that accompanies one of the recalled medications.

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)

See the full lot and expiration date information below:

These items were distributed between May 26, 2023, and April 21, 2025. Click here for the full lot number list. The FDA’s recall enforcement report does not say if the products were associated with a specific brand, but all were distributed by AvKARE, of Pulaski, Tennessee.

Consumers who have any of the products that match the above descriptions or lot numbers are urged to stop using them 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 [email protected] or fax it to 931-292-6229, even if they no longer possess the product.

Nexstar called AvKARE for more information on the recall, but did not hear back by publication time.