FDA classifies 750,000-unit eye drop recall as Class II over sterility concerns
The U.S. Food and Drug Administration has classified a voluntary recall of nearly 750,000 units of eye drops and ointments as Class II, citing a lack of assurance of sterility. Initiated by Sterling Pharmaceutical Services LLC in August 2026, the recall affects nine products sold under brands including Walgreens, AvKare, and Reliable-1. Consumers are advised to check lot numbers and expiration dates against FDA records and discontinue use if their products are affected.
Key points
- Sterling Pharmaceutical Services LLC initiated the recall on Aug. 20, 2026, and the FDA officially classified it as Class II on Sept. 21, 2026.
- The recall covers 747,844 units across nine product lines, including lubricant eye drops, hypertonicity solutions, and nighttime ointments.
- Walgreens Lubricant Eye Drops account for the largest portion of the recall, with over 500,000 units affected across single bottles and twin packs.
- A Class II classification indicates that exposure may cause temporary or medically reversible adverse health consequences, or that the probability of serious harm is remote.
- Consumers should compare their product's lot number and expiration date with the FDA Enforcement Report and stop using any matching items immediately.
Background
This recall follows a series of eye drop safety issues in 2026, including a July-August recall of nearly 40,000 Clear Eyes bottles by Prestige Brand Holdings for similar sterility concerns. The FDA's Class II designation aligns with recent recalls of hand soaps and injectable drugs, reflecting ongoing scrutiny of sterility in over-the-counter and prescription medical products.
How outlets are covering it
USA TODAY and Clarin.com both report the recall's scope and Class II classification, but Clarin.com provides a more detailed breakdown of the FDA's three-tier risk system and specific consumer guidance steps. Yahoo's coverage focuses on the Walgreens brand impact but lacks detailed product lists. All sources agree on the total unit count (747,844) and the manufacturer (Sterling Pharmaceutical Services LLC), but only USA TODAY and Clarin.com list all nine affected products with exact quantities. No source reports injuries or illnesses linked to the recalled products.
Why it matters
Non-sterile eye drops pose a direct risk to eye tissue, potentially causing irritation, inflammation, or localized infections. Given that Walgreens is a major national retailer, the recall affects a broad consumer base, and the Class II classification signals a moderate but non-negligible health risk. Consumers using these products should act promptly to avoid potential complications, especially if they experience symptoms like redness, pain, or vision changes.
What to watch
Consumers should check their eye drop products against the FDA's Enforcement Report for lot numbers and expiration dates. Those with affected products should stop using them immediately and consult a healthcare professional if they experience any eye symptoms. Sterling Pharmaceutical Services LLC has not yet responded to requests for comment, and no further regulatory action or investigation has been announced by the FDA as of Oct. 4, 2026.
- Over half a million eye drops recalled. See affected products USA Today
- More Than 500,000 Eye-Drop Products Recalled, Including Walgreens Brand, Due to Sterility Concerns people.com
- Massive recall on eyedrops that may not be sterile FOX 8 News
- Eye drop recall affects Walgreens brands. What you should check Yahoo
- The FDA orders the recall of nearly 750,000 units of eye drops due to sterility issues: affected brands and safety recommendations. Clarin.com
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