WASHINGTON, DC — The U.S. Food and Drug Administration has updated a nationwide recall for eye drops made by Sterling Pharmaceutical Services LLC, widening attention on products that may not be sterile. The recall was first started in August as a voluntary action, and the agency later classified it as Class II on Sept. 21. That designation means the affected products could cause temporary or medically reversible health effects.
The products were distributed nationwide under several brand names and sold through major retailers, including Walgreens. The FDA says the recall covers millions of bottles, and consumers are being urged to check labels, lot numbers, and expiration dates carefully before using any eye drops at home.
Sterility concerns prompted the August recall and later FDA classification
Sterling Pharmaceutical Services initiated the recall after concerns emerged that some of the eye drops might not be sterile. In its enforcement action, the FDA said the issue could expose users to products that do not meet the standards expected for ophthalmic medications.
The agency’s Class II classification is not reserved for the most severe risk level, but it still signals a meaningful safety concern. In practical terms, the FDA says use of the affected drops may lead to temporary or medically reversible adverse health consequences.
So far, the agency has not announced any injuries or illnesses linked to the recalled bottles. Even so, consumers are being told not to use any product that matches the recall details and to handle it as they would other recalled medicines.
Several Walgreens, AvKare, Reliable-1 and TRP eye drop products are included
The recall spans multiple brands produced by Sterling Pharmaceutical Services and sold under different labels. Among the affected products are AvKare carboxymethylcellulose sodium ophthalmic solution 0.5%, Reliable-1 Laboratories sodium chloride hypertonicity ophthalmic solution 5%, and Walgreens lubricating eye drops in standard and twin-pack formats.
Also included are Reliable-1 Laboratories Lubricating Tears, TRP The Relief Products Gentle Eyes Lubricant Eye Drops, Major LubriFresh P.M. Nighttime Ointment, and Cameron Pharmaceuticals lubricating eye drops. The FDA says the products were distributed through retail channels across the country, which is why the recall reaches so many households.
Consumers are advised to compare the product name, package size, expiration date, and lot number against the FDA recall notice. Because many of the items share similar ingredients and packaging, the agency is emphasizing label checks rather than relying on appearance alone.
Lot numbers and expiration dates can help identify affected bottles
The recalled AvKare products include several lot groups with expiration dates ranging from August 2026 through July 2027, along with matching twin-pack versions. Walgreens-branded lubricating eye drops are also affected across numerous lots with expiration dates from September 2026 through June 2027.
Reliable-1 Laboratories products on the list include specific lots expiring in January, June, and July 2027. TRP The Relief Products Gentle Eyes and Cameron Pharmaceuticals lubricating eye drops are also named, along with a Major LubriFresh P.M. Nighttime Ointment lot.
The FDA directs consumers to review the exact packaging against the enforcement report if they are unsure. That step matters because the recall covers many separate lot numbers rather than a single nationwide batch.
What to do if the recalled drops are in your medicine cabinet
If you find a recalled bottle in your home, the FDA says not to use it. Instead, consumers should throw it away or return it to the place of purchase, following any return instructions the retailer provides.
People who already used one of the affected products should watch for changes in vision or other eye-related symptoms. The agency says anyone with health concerns should contact a doctor right away, especially if irritation or other unexpected problems appear after use.
Because the concern is sterility, the safest response is to stop using any bottle that matches the recall rather than waiting for symptoms. Eye products go directly into a sensitive area, which is why the FDA is urging prompt action even though no injuries have been reported.
Why the recall matters for over-the-counter eye care users
Over-the-counter eye drops are common for dry eyes, itchiness, and allergy relief, so recalled products can be easy to overlook in a bathroom cabinet or purse. The FDA’s warning is meant to catch people who may have bought a backup supply weeks or months earlier and forgotten the brand name.
The agency’s notice also reflects how widely a single manufacturer can supply store brands and private-label products. In this case, one manufacturer’s products reached several retail channels under different names, making the recall more complicated for shoppers to track.
Anyone who uses eye drops regularly may want to keep an eye on expiration dates and batch information before opening a new bottle. For now, the FDA says the recalled products should be removed from use immediately until consumers confirm they are not part of the affected lots.
Leave a Reply