Massive Recall Of Eye Drops Over Safety Concerns

Torn paper revealing the word Recall in red

A massive 1.8 million cartons of eye drops have been recalled nationwide after FDA inspectors uncovered serious manufacturing violations that could compromise patient safety.

Quick Takes

Five types of eye drops distributed by AvKARE have been recalled due to manufacturing problems that raise sterility concerns.
The FDA categorized this as a Class II recall, indicating possible temporary or medically reversible health consequences.
Affected products were distributed nationwide between May 2023 and April 2025.
No injuries have been reported yet, but consumers should stop using these products immediately.
Customers can receive full refunds by completing a form attached to the recall notice.

Manufacturing Violations Prompt Nationwide Eye Drop Recall

Pharmaceutical distributor AvKARE has initiated a voluntary recall of over 1.8 million cartons of eye drops after an FDA audit revealed significant deviations from current good manufacturing practices, or “cGMP.” The recall encompasses five different ophthalmic products that were distributed across the United States between May 26, 2023, and April 21, 2025. Health officials are concerned about potential sterility issues that could pose health risks to consumers who use these products, which are designed to be placed directly into the eyes.

The affected products include Artificial Tears Ophthalmic Solution, Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium Ophthalmic Solution, Lubricant Eye Drops Solution, and Polyvinyl Alcohol Ophthalmic Solution. These are commonly used by individuals with dry eyes or other eye conditions requiring lubrication. Regulatory authorities have expressed concern that the manufacturing violations could compromise the sterility of these products, potentially introducing harmful contaminants that could cause infections or other adverse reactions.

⚠️🚨 RECALL ⚠️🚨
Alcon Laboratories has issued a voluntary nationwide recall of Systane Lubricant Eye Drops Ultra PF due to potential fungal contamination. This action follows a consumer complaint about foreign material in a sealed vial, which was identified as fungal in nature.… pic.twitter.com/VTD0ktng9p

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What Consumers Should Know About the Recall

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 illnesses or injuries have been reported in connection with these products, health officials emphasize that potential risks cannot be ruled out. Consumers who have purchased any of the affected eye drops are advised to stop using them immediately.

AvKARE is offering full credit for returns, including shipping costs. Customers seeking refunds should complete the recall form included with the recall notice and submit it to AvKARE via email or fax, regardless of whether they plan to return the product. When returning products, consumers should include a copy of the recall notice and clearly label the package “Ophthalmic RECALL.” Healthcare providers are also being advised to review their inventory and remove any affected products from circulation.

Why Manufacturing Standards Matter for Eye Products

The violations cited by the FDA specifically mention “manufacturing cGMP deviations and lack of assurance of sterility” that could lead to “products of unacceptable quality.” Current Good Manufacturing Practice regulations are essential safeguards designed to ensure that pharmaceutical products meet strict quality standards. These standards are particularly critical for ophthalmic products, which are applied directly to one of the most sensitive and vulnerable areas of the body.

Consumers who want more information about the recall or have questions about the affected products can contact AvKARE directly. A complete list of affected products, including specific lot numbers, expiration dates, and product codes, is available on the AvKARE website. This recall highlights the importance of regulatory oversight in ensuring the safety of over-the-counter health products, especially those used in sensitive applications like eye care where contamination could potentially lead to serious infections or other complications.