Safety Violation Leads To Massive Eye Drop Recall: What To Know

Pharmaceutical giant recalls 1.8 million eye drop products nationwide after FDA inspection reveals serious safety violations that could put users at risk.

Quick Takes

Five types of eye drops have been recalled by AvKARE after FDA inspectors found manufacturing violations that could compromise product sterility
The nationwide recall affects 1.8 million cartons distributed between May 2023 and April 2025
No injuries have been reported yet, but the FDA classified this as a Class II recall with potential for temporary adverse health effects
Consumers should immediately stop using affected products and can receive a full refund by completing a recall form

Manufacturing Violations Prompt Widespread Recall

A massive recall affecting over 1.8 million cartons of eye drops has been initiated after federal inspectors discovered serious manufacturing violations. Pharmaceutical distributor AvKARE announced the voluntary recall of five different eye care products distributed nationwide between May 26, 2023, and April 21, 2025. The action follows an FDA audit that identified deviations from current Good Manufacturing Practices (cGMP), raising concerns about sterility and product safety. 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.

The FDA has classified this as a Class II recall, indicating 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.” Though no specific injuries or illnesses have been reported yet, health officials warn that using compromised eye products could lead to serious complications. AvKARE stated explicitly that “it is not possible to rule out patient risks resulting from use of these products” and described them as “products of unacceptable quality.”

What Consumers Need to Know

Consumers who have purchased any of the recalled eye drops should stop using them immediately. AvKARE is advising customers to check the company website for a complete list of affected products, including specific lot numbers and expiration dates. Anyone who has purchased the recalled items can receive a full refund by completing a recall form available on the AvKARE website. The form should be submitted to the company via email or fax regardless of whether customers are returning the physical product. Healthcare providers have also been instructed to remove any affected inventory from circulation.

For those returning products, AvKARE has requested that packages include a copy of the recall notice and be clearly labeled “Ophthalmic RECALL.” The company has offered full credit for returns, including shipping costs, and has expressed regret for any inconvenience caused by the recall. This recall is being conducted with the full knowledge and cooperation of the FDA, whose regulations for good manufacturing practices ensure that medications contain the ingredients and strength they claim to have while maintaining safety standards throughout production.

Rising Concerns About Eye Drop Safety

This massive recall comes amid growing scrutiny of the eye drop industry. The FDA has increased oversight of ophthalmic products after several concerning incidents in recent years involving contaminated eye drops. The cGMP violations cited in this recall specifically relate to “lack of assurance of sterility,” which is particularly concerning for products applied directly to the eye. Sterility issues in ophthalmic solutions can potentially lead to serious infections, vision impairment, or other complications, making this recall especially significant for the millions of Americans who rely on these products daily.

Consumers with questions about the recall can contact AvKARE directly using information provided in the recall notice. Health officials emphasize that anyone experiencing adverse reactions or problems that may be related to using these products should report them to the FDA’s MedWatch Adverse Event Reporting program. While no illnesses have been reported thus far, the widespread distribution of these products over a nearly two-year period means many Americans may have the affected drops in their medicine cabinets without realizing the potential risks they pose.