In a major public health advance, the U.S. Food and Drug Administration (FDA) recently issued a voluntary recall of more than 1.8 million cartons of eye care products supplied by AvKare, a Tennessee-based pharmaceutical company. The recall was requested by BRS Analytical Services and has been issued over concerns of deviation from current Good Manufacturing Practices (cGMP), which also questioned the quality and sterility of the product.
Overview of the Recall
The recall covers almost 76,000 lots of five ophthalmic products shipped between May 26, 2023, and April 21, 2025. The recalled products are:
- NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
- NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
- NDC# 50268-126-15 Lubricant Eye Drops Solution
- NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
The products were shipped across the country and are now being recalled due to possible sterility concerns.
⚠️ Health Advisory
Although the exact health hazards of these products are not yet known, the FDA has rated this recall as a Class II, meaning that use of, or exposure to, an offending product can result in temporary or medically reversible adverse health effects. Consumers should stop using these products immediately and return them to the point of purchase for a refund or exchange.
Manufacturer’s Statement
AvKare has accepted the recall and is in communication with the FDA to deal with the issues of sterility. The firm recommends that customers check the lot numbers and the expiration dates on their eye care products to find out whether or not they have been recalled. Customers who have recalled products are invited to get return and credit information from AvKare.
Contact Information
Customers with queries or concerns regarding the recall are invited to reach AvKare at:
- Phone: 931-292-6229
- Email: customerservice@avkare.com
- Details: https://www.avkare.com/recall
For additional information and updates, consumers can check the FDA’s Enforcement Reports webpage: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports
The FDA is still keeping track of the situation and will report updates when more information is gathered. Consumers are urged to stay updated and act accordingly to protect their health and safety.
