AvKare recall overview:
- Who: AvKare is recalling more than 75,000 cases of various ophthalmic solutions.
- Why: The recall is due to manufacturing deviations from current Good Manufacturing Practices (cGMP) identified by the U.S. Food and Drug Administration (FDA), which may lead to products of unacceptable quality.
- Where: The recall is effective nationwide in the United States.
AvKare has initiated a recall of more than 75,000 cases of ophthalmic solutions due to potential quality issues stemming from manufacturing deviations.
The AvKare eye drops recall was announced following an FDA audit of manufacturer BRS Analytical Service LLC that uncovered deviations from cGMP. These deviations could result in products of unacceptable quality and safety, posing potential risks to users.
The AvKare recall affects several ophthalmic products, including Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution and Polyvinyl Alcohol Ophthalmic Solution.
These products were distributed from May 26, 2023, to April 21, 2025.
The FDA’s findings indicated a lack of assurance of sterility, which could compromise product safety. “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,” AvKare stated.
Consumers urged to immediately discontinue use of AvKare eye products
The recall notice emphasizes that consumers should immediately discontinue use of the affected products and remove them from their inventories. The products, described as eye lubricants, are used to relieve dry and irritated eyes.
The recall notice states, “Further use of this product should immediately cease,” highlighting the urgency of the situation.
AvKare has outlined a process for consumers to return the recalled products. Customers are encouraged to fill out a recall form and send it to AvKare via fax or email.
Upon receipt, AvKare will issue a return authorization form, allowing consumers to return the products to R&S Northeast LLC in Fountain Run, Kentucky. AvKare assures that full credit, including shipping costs, will be provided for returned items.
For additional information about the AvKare recall, consumers can contact AvKare’s customer service via email at [email protected] or by fax at 931-292-6229.
The company has expressed regret for any inconvenience caused by the recall and is committed to addressing the issue promptly.
AvKare says it has not received any reports of illness or injury related to the AvKare eye drops recall so far. The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.
In April 2024, Avkare issued a voluntary recall for one lot of its 750mg Atovaquone oral suspension due to concerns it was contaminated with the bacteria Bacillus cereus.
Are you affected by the AvKare recall? Let us know in the comments.
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