75,000+ Cases of Eye Care Products Recalled Nationwide Over Sterility Concerns, FDA Says Learn which AvKARE products are affected and what to do if you have them
Over 75,000 eye care products have been recalled nationwide due to possible sterility issues
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- 75,000+ eye care products have been recalled over possible sterility issues.
- Five AvKARE products sold nationwide were affected.
- The FDA warns that there is a low risk of temporary health effects if the eye drops are used.
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.
Which Eye Care Products Were Recalled?
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.
Where Were the Products Sold?
The products were distributed nationwide. The FDA and AvKARE did not specify which states or retailers carried the products.
Why Were They Recalled?
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."
What You Should Do
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 [email protected].
This story originally appeared on: Health News - Author:Amber Brenza
