A nationwide recall covers more than 747,000 units of eye drops and ointments sold under Walgreens, AvKare, Reliable-1 and other brand names after the manufacturer said it cannot guarantee the products are sterile.
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| A nationwide recall affects more than 747,000 units of eye drops and ointments sold under several brand names, including Walgreens. |
Federal regulators have classified a sweeping recall of eye care products sold across the United States, citing concerns that the items may not be sterile. The recall was initiated in August 2026 by Sterling Pharmaceutical Services LLC, an Illinois-based company, and affects products distributed nationwide under several well-known brand names.
The U.S. Food and Drug Administration classified the recall as Class II on Sept. 21, 2026. According to the agency, a Class II classification means exposure to or use of the recalled product may cause temporary or medically reversible health consequences, or that the probability of serious harm is remote.
In total, 747,844 units are covered by the recall, which includes nine products. The recall involves lubricating eye drops, a hypertonicity eye solution, and a nighttime eye ointment.
Which products are affected?
The recall spans several brand names and product types. Consumers should check the product name, lot number, and expiration date on their packaging to determine whether their item is included.
- Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5% Eye Lubricant, 0.5 fl oz (15 mL): 19,284 bottles
- AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, 0.5 fl oz (15 mL) bottles: 12,864 packs
- AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, two-count twin packs: 107,377 packs
- Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, 0.5 fl oz (15 mL): 11,083 bottles
- Reliable-1 Laboratories Lubricating Tears, 0.5 fl oz (15 mL): 47,616 bottles
- Walgreens Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5%, 0.5 fl oz (15 mL) bottles: 301,114 bottles
- Walgreens Lubricant Eye Drops, two-count twin packs: 199,600 packs
- 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
The Walgreens-branded lubricant eye drops account for the largest share of the recall, with more than 500,000 bottles and twin packs combined.
Why the recall was issued
The recall concerns a "lack of assurance of sterility," meaning the manufacturer cannot guarantee that the affected products are sterile. Eye drops and ointments that are not sterile carry a risk of introducing bacteria or other contaminants into the eye, which can lead to infection or irritation.
The FDA's enforcement report lists specific lot numbers and expiration dates for each affected product. Consumers who use any of the recalled brands should compare the lot number and expiration date on their product with the information in the FDA's Enforcement Report.
What consumers should do
Consumers who find that they have a recalled product should immediately stop using it and speak with their doctor, according to the FDA. The agency also advises contacting the retailer where the product was purchased for more information.
Sterling Pharmaceutical Services has not published a public recall notice or provided specific instructions for consumers. The company did not respond to a request for comment.
The recall comes as fall allergy season reaches its peak, a time when many people rely on lubricating eye drops and ointments to relieve dryness, itchiness, and irritation. The affected products were distributed nationwide, so consumers across the country could have purchased them.
What remains unclear
It is not yet known whether any adverse health events have been reported in connection with the recalled products. The FDA has not announced whether additional products or lots may be added to the recall.
Consumers with questions about whether a specific product is covered should check the FDA's Enforcement Report for the most current information on lot numbers and expiration dates.
IMAGE INFORMATION Image 1 Alt Text: Assorted eye drop bottles and eye care products on a pharmacy shelf Caption: A nationwide recall covers more than 747,000 units of eye drops and ointments sold under several brand names, including Walgreens.