Eye Drop Recall Expands to More Than 747,000 Products Over Sterility Concerns

A nationwide recall involving more than 747,000 bottles, twin packs, and tubes of eye care products has been expanded after concerns emerged that the sterility of the products could not be assured.

The recall affects several brands and product lines, including Walgreens, AvKare, Reliable-1 Laboratories, TRP The Relief Products, Major, and Cameron Pharmaceuticals. According to information reported by the U.S. Food and Drug Administration (FDA), the affected products were distributed across the United States.

The products include lubricating eye drops, ophthalmic solutions, and a nighttime eye ointment. The FDA classified the recall as Class II, a category generally used when exposure to a recalled product could result in temporary or medically reversible health consequences, or when the likelihood of serious harm is considered remote.

Recall began in August and was expanded in September

Sterling Pharmaceutical Services LLC, based in Dupo, Illinois, initiated the voluntary recall on Aug. 20, according to the FDA's enforcement information. The agency subsequently classified the recall on Sept. 21.

The FDA's information shows that additional lots were included in an update dated Sept. 29. The central concern listed for the affected products is a lack of assurance of sterility.

Sterility is particularly important for products that are placed directly into the eye. Unlike medicines taken by mouth, ophthalmic products are administered to a sensitive area where contamination can potentially lead to irritation, infection, or other complications.

The FDA's recall classification does not mean that every person who used one of the products will experience a health problem. Instead, the classification reflects the agency's assessment of the potential risk associated with the recalled products. The FDA explains that a Class II recall involves products that could cause temporary or medically reversible adverse health consequences, while the probability of serious health consequences is considered remote.

Which products are affected?

The recall covers nine products in different package sizes and formulations. Consumers should not assume that every product sold under a particular brand is affected. The specific product, lot number, and other identifying information are important when determining whether an item is included.

The recalled products include:

• Walgreens Lubricant Eye Drops, containing 0.5 percent carboxymethylcellulose sodium, in 0.5-fluid-ounce bottles. The affected product carries NDC 0363-8833-15, with 301,114 bottles included in the recall.
• Walgreens Lubricant Eye Drops twin packs, also carrying NDC 0363-8833-15. The recall covers 199,600 two-count packs.
• AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5 percent, sold in 0.5-fluid-ounce bottles under NDC 50268-068-15. The recall covers 12,864 packs.
• AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5 percent twin packs, listed under NDC 50268-068-02, with 107,377 packs affected.
• Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution 5 percent, sold in 0.5-fluid-ounce bottles under NDC 69618-077-55. The recall involves 11,083 bottles.
• Reliable-1 Laboratories Lubricating Tears, in 0.5-fluid-ounce bottles under NDC 69618-076-55. A total of 47,616 bottles are included.
• TRP The Relief Products Gentle Eyes Lubricant Eye Drops, containing 0.5 percent carboxymethylcellulose sodium and sold in 0.5-fluid-ounce bottles under NDC 17312-430-15. The recall includes 14,538 bottles.
• Major LubriFresh P.M. Nighttime Ointment, packaged in 0.125-ounce tubes under NDC 0904-6488-38. The recall covers 34,368 tubes.
• Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5 percent Eye Lubricant, sold in 0.5-fluid-ounce bottles under NDC 42494-448-05. The recall involves 19,284 bottles.

The FDA's enforcement system is the official source for identifying recalled products and tracking recall classifications and status.

Lot numbers are especially important

One of the most important details for consumers is that the recall does not necessarily apply to every bottle or package of these products.

The affected AvKare lots include 3161, 3245, 3260, 3298, 3299, 3300, 3301, 3302, 3305, and 3306. The listed expiration dates range from August 2026 through July 2027.

For Reliable-1 Laboratories' hypertonicity ophthalmic solution, the recalled lots include 3192, 3293, and 3336. The Lubricating Tears recall involves lots 3171, 3174, 3275, and 3304.

TRP The Relief Products products affected by the recall include lots 3279 and 3292. Cameron Pharmaceuticals products include lots 3163 and 3164, while the Major LubriFresh P.M. Nighttime Ointment recall involves lot 3183.

Consumers should therefore check the actual packaging before deciding whether their product is part of the recall.

Why sterility matters for eye products

Eye drops and ophthalmic ointments are manufactured under conditions designed to minimize contamination because they come into direct contact with the eye.

A product that is not assured to be sterile may present a different type of concern than a typical labeling or packaging error. Potential contamination can be particularly important for people who already have eye problems, have recently undergone eye procedures, use contact lenses, or otherwise have increased vulnerability to eye infections.

However, consumers should avoid assuming that exposure to a recalled product automatically means an infection or serious injury has occurred. The recall is based on the identified manufacturing or quality concern and the FDA's assessment of potential risk.

Anyone who develops concerning symptoms after using an affected ophthalmic product should seek medical advice. Symptoms such as significant eye pain, worsening redness, discharge, changes in vision, or pronounced sensitivity to light can require prompt evaluation.

What consumers should do

People who regularly use lubricating eye drops or nighttime eye ointments may want to check their medicine cabinets for the affected products.

Start by looking at the product name and package size. Next, locate the lot number and expiration date, which are generally printed on the bottle, tube, carton, or other packaging. Compare that information with the FDA's official recall information.

If the product is confirmed to be part of the recall, consumers should follow the instructions provided by the manufacturer, pharmacy, retailer, or FDA.

People who use eye medication regularly for a medical condition should also be cautious about simply stopping treatment without considering alternatives. The FDA notes that the appropriate action can depend on the specific recall and the medicine involved, and consumers with questions may wish to contact a pharmacist or healthcare professional.

The FDA also explains that recall classifications and recall depth are separate concepts. A Class II classification describes the relative health risk, while the recall's depth describes how far through the distribution system the affected product is being removed.

Why the recall remains important

The sheer number of products involved makes the recall notable. However, the quantity should be interpreted carefully because the FDA report counts products according to how they were distributed, including bottles, packs, and tubes.

For example, a twin pack represents one distributed package containing two bottles. Consequently, the reported quantity should not automatically be interpreted as the number of individual containers.

The recall also illustrates why consumers should pay attention to lot numbers rather than relying only on a brand name. A brand may continue selling unaffected products even when certain lots have been recalled.

The FDA maintains enforcement reports covering recalls and provides information about recall classifications, product quantities, reasons for recalls, and recall status.

For the latest information, consumers should consult the official FDA enforcement record and any updated instructions from the recalling company.

Source

U.S. Food and Drug Administration: FDA Enforcement Report, Event 99712.

Disclaimer: This article is for general informational purposes and is not medical advice. Recall information can change as federal regulators and manufacturers update their records. Consumers should verify the product name, lot number, expiration date, and current recall status through the FDA or the manufacturer. Anyone experiencing concerning eye symptoms should contact a qualified healthcare professional promptly. Do not stop a prescribed medication without first discussing the situation with a doctor or pharmacist.