A nationwide eye drop recall affecting 1.8 million cartons has been issued after FDA inspectors uncovered alarming manufacturing violations that could compromise patient safety.
At a Glance
- AvKARE has recalled 1.8 million cartons of eye drops distributed nationwide due to FDA inspection findings
- Five specific products, including Artificial Tears Ophthalmic Solution, distributed between May 2023 and April 2025 are affected
- The FDA categorized this as a Class II recall, indicating potential temporary or medically reversible health consequences
- No specific injuries have been reported yet, but consumers are advised to stop using these products immediately
- Full refunds are available by completing forms accompanying the recall notice
Manufacturing Violations Prompt Massive Recall
Pharmaceutical distributor AvKARE has initiated a sweeping recall of over 1.8 million cartons of eye drop products following an FDA inspection that revealed serious manufacturing concerns. The inspection uncovered deviations from current Good Manufacturing Practices (cGMP), raising concerns about product sterility and patient safety. This recall affects five specific types of lubricant and ophthalmic solutions that were distributed nationwide between May 26, 2023, and April 21, 2025, placing potentially millions of American consumers at risk.
The FDA has categorized this as a Class II recall, which indicates “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” While no specific injuries or illnesses have been reported to date, health authorities are taking no chances with products intended for use in the sensitive eye area, where contamination could lead to serious complications.
Products Affected and Consumer Action
The recall encompasses five specific AvKARE products: Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution. These eye care products are commonly used by many Americans, particularly older adults who frequently experience dry eyes and related conditions. The company is emphatic about the potential dangers, stating they cannot “rule out patient risks resulting from use of these products.”
According to the Company: “Several types of AvKare brand eyedrops have been recalled due to contamination concerns linked to manufacturing violations, which may pose a risk to users, the company announced.”.
Consumers currently in possession of these products should immediately cease using them. AvKARE has established a complete recall protocol, offering full credit including shipping costs for returns. A detailed list of affected products, including specific expiration dates and product codes, is available on the AvKARE website. The company has requested that consumers complete a recall form and submit it via email or fax, regardless of whether they intend to physically return the product.
Safety Standards and Manufacturing Integrity
The current Good Manufacturing Practice regulations are critical safeguards designed to ensure pharmaceutical products meet rigorous safety and efficacy standards. These regulations, enforced by the FDA, form the backbone of America’s pharmaceutical safety system. When companies deviate from these standards, the potential consequences can be serious, especially for products applied directly to sensitive areas like the eyes.
“The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have”, said FDA.
Healthcare providers have also been advised to examine their inventory and discard any affected products. Retailers across the nation are removing these items from shelves as the recall proceeds. For consumers who wish to return products, they should include a copy of the recall notice and clearly label the package “Ophthalmic RECALL.” This incident underscores the importance of regulatory oversight in the pharmaceutical industry and the swift action necessary when potential safety issues are identified.