Dry eye ointment is being recalled nationwide due to risk of infection
Thousands of bottles of dry eye ointment sold at Walmart and CVS are being recalled over concerns they could cause an eye infection.
Inspectors from the Food and Drug Administration (FDA) ordered the recall after finding “unsanitary conditions” at the ointment factory in Maharashtra, western India, which they feared could mean the bottles were contaminated with microbes.
The recall affects 25 lots of ointments, with customers advised to return them to stores for a full refund. No infections have been registered so far.
It comes after four Americans died after using eye drops laced with a drug-resistant bacteria that were also supplied to the US from India.
Eye drops being recalled include the eye lubricant sold by CVS (pictured)
In the previous outbreak, a further four people developed infections so severe that their eyeballs had to be removed – while 14 people suffered vision loss and 81 reported infections in their eyes.
Since then, the FDA has conducted inspections at factories across India and prompted recalls of eye drops or ointments from at least two other factories.
The latest recall concerns four eye ointments sold in the US— including Equate Lubricant Eye Ointment and CVS Health Lubricant Eye Ointment.
The FDA has not provided details about the “unsanitary conditions” that led to the recall, but in previous cases it was because workers were barefoot in factories or sterility test results were found to be backdated.
The recalled bottles would expire from April 2024 to September 2025.
It is unclear which microbes may be contaminating the bottles, but previously this was the bacterium Pseudomonas aeruginosa.
This is a particularly worrying microbe because it can ‘melt’ the eyeballs – and in severe cases cause blindness and even death.
The FDA has published a list of the recalled LOT numbers, which can be found on the side of the product’s packaging.
Brassica Pharma produces the eye drops and also makes a range of other products, including cough formulas and multivitamin syrups.
Some eye ointments and drops – such as eco brands – are more vulnerable to contamination because they do not contain preservatives, which can keep microbes at bay.
In the recall, the FDA said: ‘For patients using these products, there is a potential risk of eye infections or related harm.
‘These products are intended to be sterile.
‘Ophthalmic medications (eye medications such as eye ointments) pose a potentially increased risk of harm to users because medications applied to the eyes bypass some of the body’s natural defenses.’
They also include an ointment sold by New Jersey-based AACE Pharmaceuticals
And two Equate brand ointments available in Walmart stores (photo)
They added: ‘Consumers should stop using the recalled eye ointment and may return it to the place of purchase.’
Eye ointments are used by people with dry eyes, including contact lens wearers and adults over 50 whose eyes produce fewer tears.
The FDA conducts inspections when supplying medical products to the U.S. market, including factories in other countries such as India.