FDA recalls 27 eye drops made in ‘insanitary’ plant where operators work barefoot

The Food and Drug Administration has recalled 27 eye drops sold at major retailers including CVS, Rite Aid, Target and Walmart following a shocking report that detailed a slew of “insanitary conditions” at a factory in India.

Kilitch Healthcare India Limited voluntarily recalled lots of eye products with expiration dates ranging from November 2023 to September 2025 after visiting the pharma giant’s Mumbai plant last month and publishing a report that said personnel at the manufacturing site “were working barefoot.”

“The deputy manager of production confirmed that this is their standard practice.”

And in a room designated for washing small machine parts, an “operator was observed taking his hat off and brushing his hair,” added the report, which was conducted last month by the FDA’s Department of Health and Human Services.

The inspection also detailed cracked floors that also weren’t sealed at the cove joint — where the floor meets the wall.

The Food and Drug Administration has recalled 27 eye drops sold at major retailers including CVS, Rite Aid, Target and Walmart because they were manufactured in “insanitary conditions” where workers were barefoot.
Jeffrey Greenberg/Universal Images Group via Getty Images

In another instance, sterile bottles fell onto the non-sterile conveyor belt, and “bottles were permitted to remain on the line for filling despite falling over where the top of the bottle came in contact with the conveyor,” the report said.

Operators were also seen wiping down the conveyor belt as they leaned over sterile unfilled bottles. “The bottles were then permitted to remain on the line and progress through filling and capping.”

The recall was announced on Wednesday — about one month after an inspection by the FDA’s Department of Health and Human Services that revealed Kilitch’s “Sterile Drug Manufacturing Facility” in Mumbai, India, was not at all sterile.

The FDA posted a full list of the recalled products and lot numbers, and instructed consumers of any of the recalled eye drops to return the product to the place of purchase and report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting Program.

CVS and Rite Aid have since swiped their respective store-brand Lubricant Eye Drops and Multi Action Relief Drops from shelves, among other eye products, while Target had to ditch its High Performance Lubricant Eye Drops and Walmart had to be wary of its Equate Hydration PF Lubricant Eye Drops.

After visiting Kilitch Healthcare India Limited’s Mumbai plant last month, FDA investigators found cracked floors, non-sterile conveyor belts and instances where staffers openly brushed their hair.
via Pharma Technology

Other infected eye products are being sold under the Rugby, Leader and Velocity brands.

The Post has sought comment from Kilitch.

CVS said it “immediately stopped the sale in-store and online of all products” upon receiving notification by the FDA of the recall.

“We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers, and are fully cooperating with the FDA on this matter,” a spokesperson for the retailer told The Post.

A spokesperson for Walmart said: “We take quality and safety standards seriously for all our suppliers and are working with the manufacturer. We have removed this product from our stores and implemented a sales block at our registers. Purchasers of the product are advised to discontinue use.”

Cardinal Health, which produces products under the Leader brand name, issued a press release that warned patients of “a potential risk of eye infections that could result in partial vision loss or blindness,” and said it’s “arranging for return of all recalled products.”

A Rite Aid spokesperson told The Post: “Due to safety concerns identified by the FDA, we have removed applicable Rite Aid branded recalled products from our store shelves. Customers can return applicable recalled eye drops to Rite Aid locations for a refund.”

Representatives for Target, Rugby and Velocity have yet to respond to The Post’s request for comment.

Target’s store-brand dry eye relief lubricant eye drops were among the 27 products recalled, which comes nearly a month after the FDA recalled 26 other eye products, also for “insanitary conditions.”

This recall comes about two weeks after the FDA warned consumers against 26 other products that treat dry or irritated eyes because they could cause eye infections and potentially lead to vision loss. 

The warnings from the FDA were prompted after investigators discovered that there were “insanitary conditions” in the manufacturer’s facility, though the federal agency did not reveal the name of the manufacturer.

There were also positive bacterial test results from environmental sampling of critical drug production areas in the facility, the FDA said.

CVS and Cardinal Health, however, noted that the products in question were supplied by Velocity Pharma.