If you keep a bottle of artificial tears in a backpack, desk drawer, or bedside table, this is one of those quick safety checks worth doing. Nearly 750,000 eye-care units are being recalled after a manufacturer reported a “lack of assurance of sterility” and the U.S. Food and Drug Administration classified the action as a Class II recall. More than 500,000 of the recalled items are eye-drop products.
Sterling Pharmaceutical Services LLC of Dupo, Illinois initiated the recall on Aug. 20 for eye drops sold under multiple brand names, including Walgreens. The FDA classification as Class II is dated Sept. 21.
What Class II means
When the FDA labels something Class II, it is signaling a specific level of risk. The agency defines a Class II recall as one where “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
In other words, the FDA considers serious outcomes unlikely, but the product still does not meet requirements and should not be used.
Products included
The recall covers nine products across several labels and distributors. Walgreens accounts for a significant portion of the recalled products, along with items distributed by AvKare and Reliable-1 Laboratories, among others.
Walgreens
- 301,114 bottles of Walgreens Lubricant Eye Drops (0.5 fluid ounces)
- 199,600 packs of the twin-pack of Walgreens Lubricant Eye Drops (sold and distributed by Walgreens)
AvKare
- 12,864 packs of AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops (0.5 fluid ounces)
- 107,377 packs of the two-count twin packs distributed by AvKare
Reliable-1 Laboratories
- 11,083 bottles of Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution (0.5 fluid ounces), 5%
- 47,616 bottles of Reliable-1 Laboratories Lubricating Tears (0.5 fluid ounces)
Other products
- 19,284 bottles of Cameron Pharmaceuticals’ Carboxymethylcellulose Sodium 0.5% Lubricant Eye Drops (0.5 fluid ounces)
- 14,538 bottles of TRP The Relief Products Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%
- 34,368 tubes of Major LubriFresh P.M. Nighttime Ointment (0.125 ounces)
Why sterility matters
Eye drops are meant to be sterile because they are used in or around the eye. This recall was initiated due to a “lack of assurance of sterility,” meaning the products are being pulled because sterility could not be assured.
The practical takeaway is simple: if your product is on the recall list, stop using it.
What to do now
If you believe you have any of the recalled products listed on the FDA’s website, the guidance is straightforward: stop using the eye drops and speak with your doctor.
- Stop use immediately if you have a recalled product.
- Confirm the exact product name against the recall list on the FDA’s website.
- Contact your doctor if you believe you have an affected product.
Other recent recalls
The FDA previously announced the recall of more than 39,000 bottles of Clear Eyes Maximum Itchy Eye Relief in August, and 2.5 million bottles of Lupin Pharmaceuticals prescription eye drops due to contamination concerns in July.
