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FDA’s Latest Eye Drop Recalls Are All Made Overseas

The FDA recalled 28 different eye drop products sold over-the-counter in retail pharmacies like CVS and Target, with at least six of them being made in India, and others made in the UK and elsewhere.

The damaged eye drops were spotted by the FDA and could cause serious infection and damage to the eye, the FDA said on Nov. 3.

Of the brands, Cardinal Health’s Leader brands are all imported from India.

This is the second time imported eye drops have caused problems and made headlines in the United States. In March, the FDA urged consumers of eye drops to throw away products by EzriCare Artificial Tears and Delsam Pharma's Artificial Tears, both brands owned by Global Pharma of India.

The FDA was back at it just five months later. The FDA told consumers in August to immediately stop using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops-Eye Repair — due to bacterial and/or fungal contamination. The eye drops were found to contain the active ingredient methylsulfonylmethane (MSM), which is not approved for use in any legally marketed eye-related drugs or products in the U.S., says the FDA. That means they were imported. It is unclear where Dr. Berne imports his product from, but LightEyez says they make their product in labs in the U.K.

Another company whose product was recalled, Velocity Pharma LLC out of Farmingdale, NY, is not a manufacturer so unless they were buying from local labs, the odds of them importing the eye drops are high.

“Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the FDA said.

The agency said it has not received reports of customers getting infected, but advises people to not buy or to stop using these eye drops and to talk to a doctor if they experience symptoms of an eye infection. Symptoms include itchiness, pain, discharge or blurred vision, according to the Mayo Clinic.

Dr. Ali Raja, an optometrist from Massachusetts General Hospital in Boston, told WCVB Channel 5 news in Boston that the FDA did its work here. And that these imported eye drops must be avoided.

“Their use can actually lead to serious eye infections,” Dr. Raja said. “The FDA found that the facilities that they were manufactured in had positive bacterial test results in the areas that they use for drug manufacturing. So because those drops go directly into the eye, they can travel throughout the body which is why the FDA is asking for the products to be recalled.”

The FDA rarely orders recalls of drugs. Most drug companies voluntarily recall their drugs, putting users of imported medicines at the risk of foreign labs being honest about contaminants at the risk of massive revenue loss and the disruption of normal business operations to remedy the situation.

We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.


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