Eye Drop Recall: Walgreens, AvKare and Other Brands Affected Over Sterility Concerns
Nearly 750,000 eye-care products, including more than 500,000 Walgreens-branded units, are recalled over sterility concerns. Here is the brand list and what to check.
More than half a million Walgreens-branded eye drops are part of a wider recall of eye-care products that may not be sterile.
According to an FDA enforcement report cited by Fox Business, Sterling Pharmaceutical Services LLC initiated the recall on Aug. 20. The FDA says the total comes to 747,844 units.
Which brands and products are affected
The recall covers products sold under several brand names, all made by Sterling. Based on the FDA figures reported by LiveNOW from FOX and Fox Business:
- Walgreens: Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5%, 0.5 fl oz (15 mL) bottles (301,114 bottles), plus about 199,600 twin packs.
- AvKare: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops, as 15 mL bottles (12,864) and two-count twin packs (107,377).
- Reliable-1 Laboratories: Sodium Chloride Hypertonicity Ophthalmic Solution 5% (11,083 bottles) and Lubricating Tears (47,616 bottles).
- Cameron Pharmaceuticals: Carboxymethylcellulose Sodium 0.5% Eye Lubricant, 15 mL (19,284 bottles).
- TRP The Relief Products: Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5% (14,538 bottles).
- Major: LubriFresh P.M. Nighttime Ointment, 0.125 oz (3.5 g) tubes (34,368 tubes).
LiveNOW's report says the recall spans "nine different brand names," but the product list in both reports names six. Check the FDA's recall listing for any additional names.
How serious is it?
The FDA classified the recall as Class II. That means using or being exposed to the products "may cause temporary or medically reversible adverse health consequences," while the chance of serious harm is "remote," according to the agency.
The FDA says eye products carry a higher risk because drugs applied to the eye bypass some of the body's natural defenses. Eye drops must be sterile to lower the risk of infection. The sources do not report any illnesses linked to this recall.
Other recent eye drop recalls
This is not the only eye drop recall in the news. LiveNOW notes that on Aug. 1, nearly 12 million bottles of Rohto eye drops were recalled over similar sterility concerns. On Aug. 20, nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief were recalled over possible contamination. Those are separate actions from the Sterling recall.
A Walgreens representative did not immediately respond to Fox Business' request for comment.
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What it means for you
Look at the brand and product name on any lubricant eye drops, tears or nighttime ointment you own, and compare them with the list above. If your product matches, check the lot number against the FDA's recall listing. If it is included, stop using it immediately, as LiveNOW advises.
Matching a brand name is not enough on its own, because the recall depends on specific products and lot numbers. The sources don't say how to get a refund or replacement, so check the retailer's or manufacturer's recall notice. Anyone worried about symptoms after using eye drops should contact a health professional.
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