Eye Drop Recall Raises Sterility and Infection Concerns for Consumers Nationwide

Nearly 750,000 Eye-Care Products Sold Under Walgreens, AvKare, Reliable-1, Cameron Pharmaceuticals, TRP, and Major Brands Are Included in a Class II FDA Recall.

What Parker Waichman LLP Found

• Approximately 747,844 units are involved across nine recalled ophthalmic products.
• More than 500,000 recalled units are Walgreens-branded lubricant eye drops, including individual bottles and twin packs.
• The recall is nationwide and was initiated because of a “lack of assurance of sterility.”
• Sterility is particularly important for eye products because products placed directly into the eyes bypass some natural bodily defenses.
• People who suffer an injury after using a recalled product should preserve the bottle, packaging, lot information, receipts, and medical records because those materials may become important evidence in a potential eye drop lawsuit.

Hundreds of thousands of bottles, packages, and tubes of eye-care products distributed throughout the United States have been recalled because of a lack of assurance that the products are sterile. The recall includes commonly used lubricant eye drops and other ophthalmic products sold under several brand names, including Walgreens. For consumers who put these products directly into their eyes believing they were sterile, the recall raises important questions about potential infection, eye injuries, medical treatment, and legal rights.

Sterling Pharmaceutical Services LLC initiated the recall on August 20, 2026. The U.S. Food and Drug Administration subsequently classified the action as a Class II recall on September 21. Current recall reporting identifies nine products and approximately 747,844 units. More than 500,000 of those units were sold under the Walgreens brand.

The stated reason for the recall is a “lack of assurance of sterility.” That wording is important. It does not establish that every recalled bottle is contaminated, nor does the Class II classification establish that everyone who used the products will suffer an injury. It means there is insufficient assurance that the affected products satisfy the sterility requirements expected of ophthalmic products. The FDA explains that eye drops present a heightened potential for harm because medication placed directly into the eye bypasses some of the body’s natural defenses.

Consumers who used a recalled product and subsequently developed an eye infection, pain, discharge, inflammation, blurred or reduced vision, or another significant eye problem should seek appropriate medical care. Anyone who believes a recalled product caused an injury may also have reason to investigate whether a product liability claim can be pursued.

Which Eye Drops and Eye-Care Products Are Being Recalled?

The Sterling Pharmaceutical Services recall is broader than one Walgreens product. It encompasses nine ophthalmic products distributed under multiple labels throughout the United States.

The affected products include Walgreens Lubricant Eye Drops containing carboxymethylcellulose sodium 0.5%, including approximately 301,114 individual bottles and 199,600 twin packs. The twin packs carry NDC 0363-8833-15, and numerous lots with expiration dates extending into 2027 are affected.

Other recalled products include AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Lubricant Eye Drops, Reliable-1 Laboratories Lubricating Tears, Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution 5%, Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5% Lubricant Eye Drops, TRP The Relief Products Gentle Eyes Lubricant Eye Drops, and Major LubriFresh P.M. Nighttime Ointment.

Because recalls can be lot-specific, consumers should not determine whether a product is affected solely by looking at the brand name. The product name, NDC, lot number, expiration date, and packaging should be compared with the FDA recall information.

Consumers can review the current recall information through the FDA recall database.

Why Is Lack of Sterility in Eye Drops a Serious Concern?

Sterility is particularly important when a product is designed to be placed directly into the eye.

The FDA explains that ophthalmic drugs present a heightened risk because they bypass some of the body’s natural defenses. For that reason, drugs used in the eyes must be sterile to reduce the possibility of infection.

A lack of assurance of sterility does not necessarily mean regulators found harmful microorganisms inside every recalled product. It means the required assurance that the affected products are sterile cannot be established. That distinction matters both medically and legally.

There is also a substantial difference between a sterility concern and a confirmed contamination event. Consumers should therefore be cautious about reports suggesting that the current recall itself proves the recalled Sterling products contained bacteria or fungi. Based on the available recall information, the stated basis is lack of assurance of sterility.

Nevertheless, the potential consequences of contaminated ophthalmic products are well established. Previous FDA eye-drop investigations have involved bacterial and fungal contamination, infections, vision loss, and other serious outcomes. In an unrelated 2023 artificial-tears investigation, for example, the FDA and CDC investigated infections involving a drug-resistant strain of Pseudomonas aeruginosa, with reported permanent vision loss and a death involving bloodstream infection.

That history demonstrates why sterility problems involving products placed directly into the eye receive regulatory attention.

What Symptoms Should Consumers Watch For After Using Recalled Eye Drops?

Anyone who has used one of the recalled products should pay attention to new or worsening eye symptoms. The FDA advises consumers to stop using eye drops and contact a health care professional when they experience problems such as discharge, pain, changes in vision, or discomfort.

Symptoms potentially warranting medical evaluation can include eye redness, unusual discharge, persistent burning, pain, swelling, excessive tearing, sensitivity to light, blurred vision, decreased visual acuity, or other changes in vision.

Symptoms should not be ignored simply because the recall is categorized as Class II. A regulatory classification describes the general risk associated with a recalled product; it does not diagnose an individual patient or determine how serious a particular person’s condition may become.

People who develop significant pain, sudden visual changes, signs of infection, or rapidly worsening symptoms should obtain prompt medical evaluation. Early treatment can be important with some eye infections and other ocular injuries.

A patient should also tell the treating physician or ophthalmologist the exact name of the recalled product used, when it was used, how frequently it was used, and when symptoms began. That information may assist both medical diagnosis and any later investigation into causation.

What Does an FDA Class II Recall Mean?

The Class II designation can easily be misunderstood. A Class II recall generally concerns a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or in which the probability of serious adverse health consequences is remote.

That does not mean an affected consumer cannot sustain a serious injury. Recall classifications evaluate the regulatory situation broadly. They do not predict the outcome for every individual consumer.

Likewise, a Class II classification should not be interpreted as proof that a particular bottle caused an infection. A person pursuing a product liability case generally must establish more than the existence of a recall. Depending upon applicable state law and the legal theory asserted, evidence may be needed connecting the product, an alleged defect, and the person’s injury.

The distinction is particularly important for consumers researching an eye drop recall lawsuit. Being included in a recall and having a compensable personal injury claim are not automatically the same thing.

When Could Recalled Eye Drops Lead to a Product Liability Lawsuit?

A person who merely purchased a recalled product may be situated differently from someone who used it and subsequently developed a medically documented injury.

Potential litigation may involve allegations concerning defective manufacturing, inadequate quality controls, failure to provide adequate warnings, negligence, breach of warranty, or other theories permitted under the law of the state governing the claim. The precise causes of action can vary significantly because product liability law is largely state-specific.

For an injured consumer, several questions may become central:

• Was the specific product used included in the recall?
• Can the bottle’s lot number or other identifying information be established?
• When did the consumer begin and stop using the product?
• When did the symptoms first appear?
• What diagnosis was made?
• Is there medical evidence connecting the condition to use of the product?
• Did the patient have a preexisting eye condition or another possible source of infection?
• What medical treatment became necessary?
• Did the condition cause temporary or permanent changes in vision?
• Did the injury create lost wages, medical expenses, or continuing treatment needs?

The answers help determine whether a potential case can move beyond the fact that a recalled product was used and establish a legally supportable connection between the product and the claimed injury.

Potential Eye Drop Injuries Can Range From Temporary Irritation to Serious Vision Problems

The nature and severity of an eye injury can vary considerably. Some consumers may experience irritation that resolves after treatment. Others may require prescription medications, diagnostic testing, repeated ophthalmology appointments, or more extensive care. An infection affecting sensitive structures of the eye can potentially have much more significant consequences.

Past FDA warnings involving contaminated ophthalmic products demonstrate the potential spectrum of harm. The FDA has warned that contaminated eye drops can produce infections ranging from relatively minor conditions to serious vision-threatening infections. Some infections can potentially progress beyond the eye.

In a lawsuit, the seriousness of an injury is ordinarily established through medical evidence rather than the existence of the recall alone. Ophthalmology records, diagnostic testing, cultures when performed, prescription records, photographs, documented changes in visual acuity, and treating-provider opinions may therefore become important.

If vision impairment becomes permanent, the damages analysis may also have to consider how the condition affects employment, driving, reading, computer use, household activities, independence, and overall quality of life.

What Compensation Could Be Available in an Eye Drop Injury Lawsuit?

Damages depend upon the facts of the individual case and the law of the applicable jurisdiction.

An injured consumer may potentially seek compensation for past medical bills and reasonably anticipated future medical care associated with the injury. Treatment costs could include emergency care, ophthalmologist appointments, medications, diagnostic testing, procedures, hospitalization, or ongoing vision-related treatment.

Lost income may also become relevant when an eye injury prevents a person from working. A severe or permanent visual impairment could raise a claim involving diminished future earning capacity if the condition limits the person’s ability to perform the occupation he or she previously performed.

Non-economic damages may include physical pain, discomfort, emotional distress, and loss of enjoyment of life where permitted under applicable law. Permanent visual impairment may substantially affect these damages because eyesight influences so many aspects of daily life.

The value of a claim cannot responsibly be determined from the recall announcement alone. Diagnosis, duration, causation, treatment, prognosis, financial losses, and state law must all be considered.

Why Preserving the Recalled Eye Drop Bottle Can Be Important

One of the most important actions an injured consumer can take is to preserve the actual product.

Do not throw away the bottle, tube, box, label, cap, instructions, receipt, or other packaging if you believe a recalled eye-care product caused an injury. Do not transfer the contents into another container. The original packaging can establish the manufacturer or distributor, product identity, NDC, lot number, expiration date, and other information.

Take clear photographs of all sides of the bottle and packaging. Preserve purchase receipts, pharmacy or retailer records, online order confirmations, loyalty-account purchase histories, and credit-card statements that may help establish when and where the product was purchased.

The remaining contents can also potentially become important evidence. Anyone contemplating a claim should obtain legal advice before destroying, returning, or otherwise surrendering a product that may constitute evidence.

Medical documentation should likewise be preserved. Records created close in time to the onset of symptoms can help establish when the problem developed, what the patient reported, what doctors observed, and what treatment was prescribed.

What If You Already Threw Away the Recalled Eye Drops?

Discarding the bottle does not necessarily mean there can be no claim. Other evidence may establish product use. Retail purchase histories, receipts, photographs, online orders, medical records, emails, text messages, or testimony from household members may help identify the product.

Medical records can be especially important. If a patient told a physician which eye drops were being used before learning of the recall, that contemporaneous documentation may help establish exposure.

The loss of the actual bottle, however, can make identification and investigation more difficult. This is why consumers who still possess a potentially relevant product should preserve it rather than assume it has no evidentiary value.

Who Could Potentially Be Responsible for Injuries Associated With a Recalled Eye-Care Product?

Determining potential defendants requires investigation. Depending on the facts and governing law, litigation involving a defective consumer product may examine the conduct of a manufacturer, distributor, seller, private-label company, or other entity involved in bringing the product to market.

The fact that a consumer purchased a Walgreens-branded product, for example, does not by itself establish which entity is legally responsible for an alleged manufacturing defect. The recalled Walgreens products were manufactured by Sterling Pharmaceutical Services and distributed under the Walgreens label. The broader recall also involves products distributed under several other labels.

A product liability investigation may therefore examine manufacturing records, quality-control procedures, testing, regulatory communications, distribution agreements, recall documents, complaints, adverse-event reports, and what the involved companies knew or should have known about a potential problem.

Those questions become particularly important if litigation develops involving numerous injured consumers in different states.

A Recall Does Not Automatically Prove a Lawsuit

Consumers should understand this distinction before assuming that ownership of a recalled bottle guarantees compensation.

An FDA recall is highly relevant evidence, but a personal injury lawsuit normally requires an actual injury and proof supporting causation. Someone who purchased a recalled bottle but never used it and suffered no physical injury may have fundamentally different legal rights from someone who used an affected product and was subsequently diagnosed with an eye infection or vision damage.

Similarly, developing an eye condition after using the product does not by itself conclusively establish that the product caused it. Medical and factual investigation is necessary.

A product liability attorney can examine the timing of product use and symptoms, medical diagnosis, alternative causes, recall information, product identification, and other evidence to determine whether a viable claim may exist.

Deadlines Can Apply to Recalled Eye Drop Lawsuits

Every state imposes deadlines that can limit how long an injured person has to bring a product liability or personal injury lawsuit. Those deadlines are commonly known as statutes of limitations.

The applicable period is not necessarily the same nationwide. The deadline may depend on the state, type of claim, date of injury, date an injury reasonably could have been discovered, age or legal status of the injured person, identity of the defendants, and other circumstances.

Consumers should therefore not assume that the date of the FDA recall establishes the deadline for filing a lawsuit.

Waiting can create another problem: evidence can disappear. Packaging may be discarded, purchase histories may become harder to obtain, witnesses may forget details, and relevant records may become more difficult to locate. Early investigation can help preserve evidence regardless of the ultimate filing deadline.

Recalled Eye Drops Lawsuit FAQs

Can I File a Lawsuit If I Used Recalled Walgreens Eye Drops?

Potentially. Using a recalled product alone does not automatically establish a personal injury lawsuit. A stronger potential claim generally exists when a consumer can establish use of an affected product, a subsequent medically documented injury, and evidence supporting a causal relationship between the two. The product’s lot number, purchase information, medical records, diagnosis, and timing of symptoms may all become important. Because product liability laws differ by state, an attorney must evaluate the individual facts and applicable law.

What If My Eye Infection Started Before I Heard About the Recall?

The date you learned about the recall is not necessarily the date that matters for determining causation. If you used an affected product and subsequently developed symptoms, medical records may establish when those symptoms began and what your doctors observed. Tell your attorney when you purchased the product, when you used it, when symptoms first appeared, and when you received treatment. The sequence of events can become an important part of the investigation.

Do I Need to Keep My Recalled Eye Drop Bottle?

If you believe the product may have caused an injury, preserving it can be very important. Keep the bottle or tube, cap, box, inserts, receipts, and any other packaging. Photograph the label, NDC, lot number, and expiration date. Do not alter the contents or transfer them to another container. Before returning or destroying a potentially relevant product, consider obtaining legal advice about preserving evidence.

What Injuries Could Potentially Be Associated With Non-Sterile Eye Drops?

Contaminated ophthalmic products can potentially cause infections and other ocular complications. The FDA has previously warned in unrelated eye-drop cases about infections capable of causing partial vision loss or blindness. The current Sterling recall, however, is based on a lack of assurance of sterility, which should not be mischaracterized as proof that every recalled unit was contaminated. Anyone experiencing pain, discharge, redness, discomfort, or changes in vision after using an affected product should seek medical attention.

How Long Do I Have to File an Eye Drop Lawsuit?

The deadline depends on the state and circumstances of the claim. Different states have different statutes of limitations, and rules concerning when the limitation period begins can vary. Waiting until the recall investigation is completed can create unnecessary legal risk. An attorney can determine which state’s law applies and calculate potential filing deadlines based on the individual facts.

Contact Our Eye Drop Injury Lawsuit Attorneys

Consumers should be able to use over-the-counter eye-care products without being exposed to an unreasonable risk of infection or preventable eye injury. If you used recalled Walgreens, AvKare, Reliable-1, Cameron Pharmaceuticals, TRP, Major, or another affected eye-care product and subsequently suffered an infection, vision problems, or another injury, your circumstances should be investigated.

Parker Waichman LLP is a national law firm representing people injured by allegedly defective and dangerous products. Our attorneys can review the recalled product, your medical history, the timing of your symptoms, and other evidence to determine whether you may have grounds to pursue compensation.

Preserve the product and its packaging whenever possible, along with photographs, receipts, medical records, and other evidence documenting your purchase, product use, and injury.

For a free consultation concerning a recalled eye drop lawsuit, call Parker Waichman LLP at 1-800-YOUR-LAWYER (1-800-968-7529). There is no charge for the initial consultation. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.