Nationwide Recall: Over 75,000 Eye Care Products Pulled Due to Sterility Risks, FDA Warns
In recent news, over 75,000 eye care products have been recalled due to potential sterility issues. This significant recall was initiated by pharmaceutical lab BRS Analytical Service, LLC and affects various products sold by AvKARE across the nation. The FDA has issued a warning, stating that there is a low risk of temporary health effects associated with the use of these eye drops. It is essential to check your medicine cabinet if you own any of the affected items.
On April 23, BRS Analytical Service, LLC voluntarily recalled multiple ophthalmic solutions as they were deemed to be of “unacceptable quality” by the FDA and distributor AvKARE. Below, we will delve into the specifics of this recall and what it means for consumers.
Which Eye Care Products Were Recalled?
The recall specifically affects the following five products distributed by AvKARE:
- 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 products were shipped over a two-year span, from May 26, 2023, to April 21, 2025. For detailed information regarding specific lot codes and expiration dates, please refer to the AvKARE news release.
Where Were the Products Sold?
The recalled products were distributed nationwide. However, neither the FDA nor AvKARE has provided specific details on which states or retailers carried these products. If you suspect you own any of the recalled items, it is crucial to take immediate action.
Why Were They Recalled?
The recall was prompted by an FDA audit that uncovered “manufacturing cGMP deviations” at BRS Analytical Services, LLC. CGMP, or Current Good Manufacturing Practice, refers to the regulations established by the FDA to ensure that drugs are manufactured to meet quality standards.
While it remains unclear whether these cGMP deviations pose a health risk, AvKARE stated, “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.” Additionally, the FDA has highlighted a “lack of assurance of sterility” as a key reason behind the recall.
On May 6, the FDA classified this eye care product recall as having a Class II risk level. This classification indicates that the products may “cause temporary or medically reversible adverse health consequences,” but the chances of serious adverse reactions are considered remote.
What You Should Do
If you own any of the recalled eye care products, it is essential to take the following steps:
- Stop using them immediately.
- Report your product using the form available on the AvKARE recall page.
- Return the product for a full refund, including any shipping costs.
- Contact customer service for any questions at customerservice@avkare.com.
The health and safety of consumers should always come first. By staying informed and taking the necessary precautions, you can protect yourself and your loved ones from potential risks associated with these eye care products. Check your cabinets and act accordingly!
