The TAIM ExchangeU.S. Food and Drug Administration has issued a recall on eye ointments by multiple brands over "lack of sterility assurance" at the facility in India, where the products were being manufactured.

The FDA, in its recall notice issued Monday, said that the Thane-based manufacturer Brassica Pharma Pvt. Ltd. is voluntarily recalling the products after federal inspectors found unsanitary conditions at their facility. However, the company has not received any reports of the ointments having adverse effects on consumers.

"For those patients who use these products, there is a potential risk of eye infections or related harm," says the FDA, in the notice. "These products are intended to be sterile."

"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," it adds.

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Eye ointments recall: Which products are being recalled?

The recalled products under the brands Equate, CVS Health and AACE Pharmaceuticals were being sold nationwide at multiple retailers including Walmart and CVS, according to the FDA, with expiration dates from April 2024 to September 2025.

The recalled products include:

• Equate Lubricant Eye Ointment in a 3.5-gram tube, packaged in a cardboard box with UPC code: 681131395298.
• Equate Style Lubricant Eye Ointment in a 3.5-gram tube in cardboard box with UPC code: 681131395304.
• CVS Health Lubricant Eye Ointment in a 3.5-gram tube in box with UPC code: 050428634141.
• Lubricant PM Ointment by AACE Pharmaceuticals in a 3.5-gram tube, sold in box with UPC code: 371406124356.

Eye ointments recall: What to do if you have been using the brands recalled

The FDA has advised consumers to immediately stop using the recalled eye ointments and return them to the place of purchase.

Questions regarding the recall can be directed to Brassica Pharma Pvt. Ltd. at (833)-225-9564 or [email protected].

Those experiencing any adverse effects after using the products should contact their physician or healthcare provider immediately, said the FDA and report the issue to FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Eye drops recalled by FDA

In January 2024, the FDA issued a recall for copycat eye drops that could be contaminated and potentially pose an infection rick. In 2023, multiple eye drops were recalled. The FDA warned consumers to stop purchasing a host of over-the-counter eye drops due to a potential risk of infection that may lead to partial vision loss or blindness.

Contributing: Gabe Hauari