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An eye drop recall involving 747,844 units sold under nine brand names has raised concerns among consumers across the United States. The Food and Drug Administration says the products may not be sterile and advises people to check their bottles and packages before using them.
The recalled products were manufactured by Sterling Pharmaceutical Services in Dupo, Illinois. They include lubricant eye drops, lubricating tears, an ophthalmic solution and an ointment. While the FDA says the likelihood of serious health consequences is remote, affected products could potentially cause temporary or medically reversible problems.
Critical Eye Drop Recall Affects Nine Brands
The FDA’s recall includes products sold by familiar names such as Walgreens, AvKare and Major. The agency lists a total of 747,844 bottles, packs and tubes affected by the action.
- Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5% Eye Lubricant: 19,284 bottles.
- AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%: 12,864 packs.
- AvKare two-count twin packs: 107,377 packs.
- Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution 5%: 11,083 bottles.
- Reliable-1 Laboratories Lubricating Tears: 47,616 bottles.
- Walgreens Lubricant Eye Drops: 301,114 bottles.
- Walgreens two-count Lubricant Eye Drop twin packs: 199,600 packs.
- TRP The Relief Products Gentle Eyes Lubricant Eye Drops: 14,538 bottles.
- Major LubriFresh P.M. Nighttime Ointment: 34,368 tubes.
What a Class II Recall Means for Consumers
The recall was initially issued on August 20 and was upgraded to a Class II recall on September 21. According to the FDA, a Class II recall covers products that may cause temporary or medically reversible adverse health consequences. The agency also says the probability of serious harm is considered remote.
Nonsterile eye care products can be especially concerning because they are applied directly to the eyes. Contaminated or improperly manufactured drops may cause irritation, discomfort, redness or infection. People with existing eye conditions, recent eye procedures or weakened immune systems should be especially cautious.
Powerful Safety Steps After the Recall
Consumers who have any of the listed products should not assume that every bottle or package is affected. The FDA advises checking the product’s lot number against the official recall information. If the lot number matches, stop using the product immediately.
Do not share recalled eye drops with another person, and avoid throwing them into a household medicine cabinet for later use. Consumers should follow pharmacy or local disposal guidance. Anyone who experiences pain, worsening redness, discharge, vision changes or continuing irritation after using an affected product should contact a medical professional promptly.
People who rely on artificial tears or nighttime ointment may need to choose an alternative product. However, consumers should speak with a pharmacist, optometrist or doctor if they use eye medication regularly or have been instructed to use a specific treatment.
Other Recent Eye Care Recalls
The latest action is part of a series of eye product recalls reported in recent months. On August 1, nearly 12 million bottles of Rohto eye drops were recalled over concerns that they might not be sterile. Those products were marketed for redness, dryness and eye strain relief.
On August 20, nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops were also recalled because of potential contamination concerns. The separate recalls highlight why consumers should periodically review the FDA’s safety notices and check products already stored at home.
Frequently Asked Questions About the Eye Drop Recall
Why were these eye drops recalled?
The FDA says the products may not be sterile. The recall affects items made by Sterling Pharmaceutical Services and sold under nine brand names.
Are all Walgreens eye drops recalled?
No. The recall applies only to specific Walgreens lubricant eye drop bottles and twin packs identified by their product and lot information.
What should I do if I have a recalled product?
Check the lot number, stop using the product if it is included, and follow appropriate disposal or return instructions. Contact a healthcare professional if symptoms develop.
Is this a Class I recall?
No. The FDA classified the action as Class II, meaning the products may cause temporary or medically reversible health effects, while serious consequences are considered unlikely.
