26 More Eyedrops Recalled from CVS, Target, Walmart, Rite Aid and More

On October 27, 2023, the United States Food and Drug Administration (FDA) issued a warning to consumers to avoid using 26 over-the-counter eye drops sold under multiple brands, including CVS Health, Leader and Rugby (which are Cardinal Health brands), Rite Aid, Target Up & Up, Walmart, and Velocity Pharma.

This set of warnings has warranted recalls of multiple OTC eye drops, building on the extensive record of recalled drops in the past year.

According to the FDA warning statement, the most recent recalls are linked to potential eye infection risks that could cause partial or total vision loss. Much like the other recalls this year, these recalls are a byproduct of sterility issues in the ophthalmic drugs.

The FDA emphasizes that sterility issues and bacterial contamination in ocular products are hazardous for consumers, as these drugs bypass natural biological defenses intended to protect against infection.

The recalls include the following products:

• CVS Health Lubricant Eye Drops 15 mL (Carboxymethylcellulose Sodium Eye Drops 0.5% w/v), single and twin packs
• CVS Health Multi-Action relief Drops 15 mL (Polyvinyl Alcohol 0.5% w/v & Povidone 0.6% w/v & Tetrahydrozoline Hydrochloride 0.05% Eye Drops)
• Rugby Lubricating Tears Eye Drops 15 mL (Hypromellose 2910-0.3% w/v & Dextran 70- 0.1% Eye Drops)
• Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 mL (Polyvinyl Alcohol Eye Drops 1.4% w/v)
• Leader Dry Eye Relief 10 mL (Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops)
• Rite Aid Gentle Lubricant Gel Eye Drops 15 mL (Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% Eye Drops)
• Target Up&Up Extreme Relief Dry Eye 15 mL (Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops)
• Velocity Pharma LLC Lubricant Eye Drop 10 mL (Propylene Glycol Eye Drops 0.6% w/v)
• Walmart Equate Hydration PF Lubricant Eye Drops 10 mL (Polyethylene Glycol 400 0.4% & Propylene Glycol 0.3% Eye Drops)

A comprehensive list of recalled products can be found on the FDA’s website.

Although the warning statements were released to the public by the FDA on October 27, 2023, and October 30, 2023 (for the Walmart drops), the companies received notifications from the administration on October 25, 2023, suggesting they recall their products after FDA investigators identified unsanitary manufacturing conditions and contaminated samples.

When the public notification was released, CVS, Rite Aid, and Target responded to the FDA, noting that they would remove the products from store shelves and websites. Since the notifications and public warning letters, multiple companies have responded with voluntary recalls of affected products.

For example, on October 31, 2023, The Harvard Group LLC issued a voluntary recall of the Rugby Laboratories eye drops mentioned in the FDA warning. According to the recall notice issued by the company, unsanitary manufacturing conditions prompted the recall of these products distributed across the US since June 1, 2021.

The release revealed that Velocity Pharma LLC, based in Farmingdale, New York, supplied the products. Cardinal Health also announced that Velocity Pharma provided the Leader brand eye drops.

Based on the information from the Cardinal Health and Harvard Group press releases, three adverse events have been linked to recalled products manufactured by Velocity Pharma. According to an article in the Washington Post, the retailers of all the eyedrops have identified Velocity Pharma as the supplier. The supplier has not issued a statement so far.

However, the American Optometric Association (AOA) responded to these recalls by recommending that patients avoid the affected products and visit a licensed healthcare professional if they are experiencing new or prolonged eye irritation after using the products.

Additionally, the AOA explained, “It’s important to note that eye drops are safe when manufactured and used properly. The AOA recommends all patients consult with their local AOA optometrist before purchasing eye drops to ensure an appropriate treatment plan is in place. When talking with a doctor of optometry, it’s also important to share any prescribed and over-the-counter medications currently in use to avoid health complications.”

Beyond identifying potential dangers to patients, this set of recalls may highlight a broader issue in standard operating procedures for eye drops, as contamination and possible bacterial infections have been a common theme in the continuous train of recalls.

For example, the first recall this year, issued in February 2023 by Global Pharma Healthcare, was due to contamination by Pseudomonas aeruginosa, which infected dozens of patients and contributed to multiple instances of vision loss. The company has since issued a recall on Ezricare and Delsam Pharma Artificial Tears in addition to the Delsam Pharma Artificial Eye Ointment.

Additionally, Apotex Corp recalled its Brimonidine Tartrate Ophthalmic Solution, while Pharmedica USA LLC recalled its Purely Soothing, 15% MSM drops linked to sterility issues. Beyond that, recalls were issued on Dr. Berne’s MSMS Drops 5% Solution, LightEyez MSM Eye Drops, and Clear Eyes Once Daily, Eye Allergy Itch Relief.

A deep dive by the FDA into the Global Pharma eye drop plant identified a minimum of 19 quality control violations or irregularities that could contribute to sterility issues. The administration also cited unclean environments and equipment. The company has since been on an import alert, preventing them from selling any products domestically.

To date, no details have been released about the unsanitary conditions responsible for the current recall; however, a spokesperson for Cardinal Health told the Washington Post that they are working with the supplier and the FDA to evaluate the unsanitary manufacturing conditions.

While post-market monitoring, evaluation, and adverse event reporting allowed the FDA to identify and remove multiple consumer safety hazards from the market, it did not prevent the present recalls.

Some consumers are critiquing the FDA for not identifying these risks earlier. For example, Teresa Murray, Consumer Watchdog at the US PIRG Education Fund, told CBS News, "This is infuriating for a few reasons. First, prior to this FDA warning, there have been three major eye drop recalls this year for bacterial contamination or unsterile products. Why has it taken this long for the FDA to discover this much broader problem?”

Although that question remains unanswered, the FDA maintains that it is doing its best to monitor the recalls. Whether this saga of events will impact manufacturing oversight protocols or standard operating procedures is still unknown.

Until then, consumers and healthcare professionals should monitor the FDA website for updates. Additionally, individuals using eye drops should check the recall list and discard any affected drops appropriately, contacting a healthcare provider if they are experiencing any symptoms. Patients concerned about using their eye drops should consult an optometrist or ophthalmologist to discuss ways to minimize the risk of ocular infections and adverse events.