75,000+ Cases of Eye Care Products Recalled Nationwide

Check your medicine cabinets: More than 75,000 cases of eye care products have been recalled nationwide due to potential manufacturing issues that could affect product sterility.

On April 23, pharmaceutical lab BRS Analytical Service, LLC voluntarily recalled five different ophthalmic solutions—including eye drops and artificial tears—because they may be of “unacceptable quality,” according to the Food and Drug Administration and distributor AvKARE.

The following five products were distributed nationwide by AvKARE and are part of the recall:

• 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)

The products were shipped over a two-year period, from May 26, 2023, through April 21, 2025.

For specific lot codes and expiration dates, see the AvKare news release.

The products were distributed nationwide. The FDA and AvKARE did not specify which states or retailers carried the products.

An FDA audit uncovered “manufacturing cGMP deviations” at BRS Analytical Services, LLC.

CGMP stands for Current Good Manufacturing Practice—regulations set by the FDA to ensure drugs meet their quality standards through manufacturing processes.

It’s unknown if these cGMP deviations come with a health risk, but according to AvKare, “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 FDA also noted a “lack of assurance of sterility” as the reason for the recall.

On May 6, the FDA gave the eye care product recall a Class II risk level, indicating that they may “cause temporary or medically reversible adverse health consequences,” but that the “probability of serious adverse health consequences is remote.”

If you have any of these products at home:

• Stop using them immediately.
• Report your product using the form on the AvKARE recall page.
• Return the product for a full refund, including shipping costs.
• Contact customer service with questions at customerservice@avkare.com.