Thousands of bottles of ointments for dry eyes sold in Walmart and CVS are being recalled over fears they could cause an eye infection.
Inspectors from the Food and Drug Administration (FDA) ordered the recall after finding ‘unsanitary conditions’ at the ointments factory in Maharashtra, west India, which they feared could mean the bottles were contaminated with microbes.
The recall is for 25 lots of the ointments, with customers advised to return them to stores for a full refund. No infections have been recorded to date.
It comes after four Americans died after using eyedrops laced with a drug-resistant bacteria that were also supplied to the US from India.
Eyedrops that are being recalled include the Lubricant Eye Ointment sold by CVS (pictured)
In the previous outbreak, another four people also suffered infections that were so severe their eyeballs had to be removed — while 14 suffered from vision loss and 81 reported infections in their eyes.
Since then, the FDA has carried out inspections at factories across India and triggered recalls of eyedrops or ointments from at least two other factories.
The latest recall is for four eye ointments sold across the US— including Equate Lubricant Eye Ointment and CVS Health Lubricant Eye Ointment.
The FDA did not detail the ‘unsanitary conditions’ that triggered the recall, but in previous cases, this has been because workers were barefoot in factories or were found to be backdating results of sterility tests.
The recalled bottles were set to expire from April 2024 to September 2025.
It is unclear what microbes may be contaminating the bottles, but previously this has been the bacteria Pseudomonas aeruginosa.
This is a particularly concerning microbe because it can ‘melt’ the eyeballs — and in severe cases can cause blindness and even death.
The FDA has published a list of the LOT numbers being recalled, which can be found on the side of the product’s packaging.
Brassica Pharma manufactures 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 notice, the FDA said: ‘For patients who use these products, there is a potential risk of eye infections or related harm.
‘These products are intended to be sterile.
‘Ophthalmic drugs [eye drugs like eye ointments] pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.’
They also include an ointment sold by AACE Pharmaceuticals, which is based in New Jersey
And two ointments from the Equate brand which are available in Walmart stores (pictured)
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 years old whose eyes produce fewer tears.
The FDA carries out inspections supplying medical products to the US market, including factories in other countries — such as India.
