Recall alert: 75K cases of eye drops recalled

Tens of thousands of cases of eye drops have been recalled by BRS Analytical Services.

The recall was initiated on April 23, but the Food and Drug Administration listed it as a Class II on May 6, according to agency documentation.

In all, 75,795 cases have been recalled, or 1.8 million cartons of eye drops.

The reason for the recall is the potential lack of sterility and cGMP deviations. The term cGMP stands for Current Good Manufacturing Practice, or the rules that ensure that systems used to produce medications have the “proper design, monitoring, and control of manufacturing processes and facilities” to ensure medications are what they say they are, have the correct strength, quality and purity, the FDA said.

The following products are part of the recall:

• Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% Lubricant Eye Drops
• Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethylcellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel
• Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethylcellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing
• Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing
• Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing

All five types of eye drops were distributed by AvKARE and came in .5 FL OZ per dropper bottles.

Click here to see the list of lot numbers and expiration dates.

They were shipped from May 26, 2023, to April 21, 2025.

A letter from AvKARE said that the deviations were found during an FDA audit and that the “hazard to the user is unknown.”

Live Now Fox and Scripps News reported that the eye drops should not be used. Stores with inventory of the recalled treatments should remove them from shelves and ship them to the company, AvKARE advised.