Sterling Pharmaceutical Services Recalls 747,844 Eye Drops Over Sterility Concerns
The U.S. Food and Drug Administration (FDA) has classified a nationwide recall of 747,844 eye drops and ophthalmic ointment units as Class II due to a lack of sterility assurance during manufacturing, according to USA Today. Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, initiated the voluntary recall on August 20, 2026, which the agency officially designated on September 21. Ophthalmic products carry heightened infection risks because drugs applied directly to the eyes bypass the body’s natural defenses and must be sterile.
Walgreens Inventory Accounts For Majority Of Affected Products
Major national pharmacy chain Walgreens accounts for more than two-thirds of the total recalled inventory across nine distinct product lines. The affected items include lubricant eye drops, hypertonicity solutions, and nighttime ointments sold under various brand names. The specific recalled quantities include 301,114 single bottles and 199,600 two-count twin packs of Walgreens Lubricant Eye Drops. Additional impacted brands include Cameron Pharmaceuticals, AvKare, Reliable-1 Laboratories, TRP The Relief Products, and Major Pharmaceuticals.
Full List Of Recalled Eye Drops And Ointments
Consumers checking their medicine cabinets can identify the recalled merchandise across the nine designated product lines. The exact inventory totals reported by USA Today comprise:
- Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5% Eye Lubricant (15 mL): 19,284 bottles
- AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (15 mL): 12,864 individual bottles and 107,377 two-count twin packs
- Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution 5% (15 mL): 11,083 bottles
- Reliable-1 Laboratories Lubricating Tears (15 mL): 47,616 bottles
- Walgreens Lubricant Eye Drops (15 mL): 301,114 single bottles and 199,600 two-count twin packs
- TRP The Relief Products Gentle Eyes Lubricant Eye Drops: 14,538 units
- Major LubriFresh P.M. Nighttime Ointment (3.5 g tubes): 34,368 tubes
Class II Designation And Health Risks Explained
An FDA Class II recall signfies that exposure to the non-sterile formulations may cause temporary or medically reversible adverse health consequences. Because these solutions touch delicate eye tissue directly, non-sterile products create an inherent risk of surface inflammation, localized eye irritation, or infection. Federal regulators actively monitor the U.S. marketplace by conducting routine surveillance, collecting samples, testing products, and tracking consumer side effects.
Frequently Asked Questions About The Sterling Pharmaceutical Recall
What specific manufacturing issue triggered the recall?
Sterling Pharmaceutical Services LLC initiated the voluntary action after identifying a lack of sterility assurance during the manufacturing process.
When did the FDA officially designate the enforcement action?
The FDA designated the recall as Class II on September 21, 2026, following the initial manufacturer action on August 20, 2026.
Where were the affected ophthalmic products sold?
The products were distributed nationwide through major outlets including Walgreens under brand names such as AvKare, Cameron, Reliable-1, Major, and The Relief Products.
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