Popular Stye and Lubricant Eye Ointments Recalled Due to Lack of Sterilization

The FDA warns consumers about possible eye infections

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A handful of lubricant eye ointments have been voluntarily recalled after the manufacturer, Brassica Pharma, noted that their facility lacked proper sterilization processes.

The recall comes after the U.S. Food and Drug Administration reported insufficient sterilization during a recent inspection of the manufacturing facility. However, the FDA’s February 26 report did not provide details about the specific sterilization lapses discovered during the inspection.

Check Equate, CVS Eye Ointment Expiration Dates

Select lots of Equate brand lubricant eye and stye ointments, as well as CVS Health lubricant eye and PM ointments, are being pulled from store shelves. The affected products have expiration dates ranging from February 2024 to September 2025.

Specifically, the recalled products are:

• Equate Lubricant Eye Ointment in a 3.5-gram tube, packaged in box with UPC code: 681131395298.
• Equate Style Lubricant Eye Ointment in a 3.5-gram tube in 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 in a 3.5 gram tube, sold in box with UPC code: 371406124356.

The manufacturer has distributed these products nationwide to wholesalers, retailers, and major stores including Walmart and CVS, as well as distributors including AACE Pharmaceuticals Inc.

The FDA has instructed stores and distributors to return any affected products to the manufacturer, Brassica Pharma, by mail. Consumers, distributors, and retailers should immediately stop using or distributing the recalled eye ointments.

According to an FDA press release, using these products could potentially cause eye infections. As of February 16, neither the FDA nor Brassica Pharma have received any reports of adverse events from using these products.

Consumers with questions can contact Brassica Pharma at 1-833-225-9562 or [email protected]. Anyone who has experienced problems after using the recalled eye ointments should also notify their healthcare provider and report it to the FDA’s MedWatch program either online, by regular mail or by fax.

What Do Eye Ointments Treat?

Eye ointments differ from eye drops in their formulation. Ointments have a semisolid, jelly-like texture similar to petroleum jelly, while drops are liquid. Ointments are often prescribed to treat conditions like pink eye, keratitis (inflammation of the cornea), blepharitis (inflammation of the eyelid), and uveitis (inflammation inside the eye). These medicated ointments typically contain antibiotics and require a prescription.

However, some ointments are also available over-the-counter, such as the medications being recalled. These treat common issues such as styes and dry eyes. Over-the-counter eye ointments tend to contain mineral oil or petroleum jelly.

Using eye products, such as eye drops and eye ointment, carries inherent risks, according to the FDA, primarily due to the potential for medication to bypass the body’s natural defenses. If any bacteria or other germs are present in the medication, they can also pass through the body and enter the eye or bloodstream. Adverse reactions to eye ointments typically manifest as redness, swelling, discharge, pain, or changes in vision.

Second India-Based Eye Medication Recall in Months

Brassica Pharma, the manufacturer involved in this new recall, is located in Thane, India. This latest recall comes after a similar incident in November 2023, when an India-based company recalled 27 types of eye drops sold at major U.S. retailers.

That recall involved popular eye drop products sold at CVS, Rite Aid, Target, and Walmart. It was initiated after the FDA found unsanitary conditions and positive bacterial tests at the manufacturer Kilitch Healthcare India’s facility. The agency warned that the contaminated eye drops could potentially cause partial vision loss or blindness.