FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products – Agency Warns Eight Companies Regarding Their Unapproved Ophthalmic Drugs
[11/15/2023] The manufacturer, Kilitch Healthcare India Limited, has issued a voluntary recall for these products. FDA recommends confirming the products on the list the agency provided.
[11/3/2023] Cardinal Health Inc. has initiated a voluntarily recall for all lots of six Leader brand ophthalmic products. The list FDA provided on October 27 included five products branded as Leader. The list has been updated to include the sixth product.
Additionally, Harvard Drug Group LLC also initiated a voluntary nationwide recall for all lots of two Rugby Laboratories brand eye drops.
The agency has updated the list of products to include the national drug codes (NDCs) that have been confirmed. FDA will provide additional information as it becomes available.
[10/30/2023] FDA is updating the list of over-the-counter eye drop products consumers should not purchase or use to include Equate Hydration PF Lubricant Eye Drop 10 mL sold by Walmart in stores and online. Walmart is removing the product from their store shelves and website.
[10/27/2023] FDA is warning consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately. These products are marketed under the following brands:
- CVS Health
- Leader (Cardinal Health)
- Rugby (Cardinal Health)
- Rite Aid
- Target Up & Up
- Velocity Pharma
These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.
FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. FDA also recommends consumers properly discard these products.
CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby and Velocity may still be available to purchase in stores and online and should not be purchased.
FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at Medwatch; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Eye Drop Retailers and Product Information
| Retailer/Brand | Product | Product Information | National Drug Code (NDC) |
| CVS Health | Lubricant Eye Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 0.5% | 76168-702-15 |
| CVS Health | Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | 76168-702-30 |
| CVS Health | Lubricant Gel Drops 15 ml (single pack) | Carboxymethylcellulose Sodium 1% | 76168-704-15 |
| CVS Health | Lubricant Gel Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 1% | 76168-704-30 |
| CVS Health | Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline Hydrochloride 0.05% | 76168-706-15 |
| CVS Health | Lubricant Gel drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 76168-712-10 |
| CVS Health | Lubricant Eye Drops 10 ml (single pack) | Propylene Glycol 0.6% | 76168-714-10 |
| CVS Health | Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | 76168-714-20 |
| CVS Health | Mild Moderate Lubricating Eye Drops 15 ml (single pack) | Polyethylene Glycol 400 0.25% | 76168-711-15 |
| Leader (Cardinal Health) | Eye Irritation Relief 0.5 FL OZ (15 ml) | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | 70000-0087-1 |
| Leader (Cardinal Health) | Dry Eye Relief 0.5 FL OZ (15 ml) | Carboxymethylcellulose Sodium 1% | 70000-0089-1 |
| Leader (Cardinal Health) | Lubricant Eye Drops 0.5 FL OZ (15 ml) (single) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-1 |
| Leader (Cardinal Health) | Lubricant Eye Drops 0.5 FL OZ (15 ml) (twin pack) | Carboxymethylcellulose Sodium 0.5% | 70000-0090-2 (carton)70000-0090-1 (bottle) |
| Leader (Cardinal Health) | Dry Eye Relief 0.33 FL OZ (10 ml) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 70000-0088-1 |
| Leader (Cardinal Health) | Lubricant Eye Drops 0.33 FL OZ (10 ml) | Polyethylene Glycol 0.6% | 70000-0587-1 |
| Rugby (Harvard Drug Group) | Lubricating Eye Drops 0.5 oz (15 ml) | Polyvinyl Alcohol 1.4% | 0536-1325-94 |
| Rugby (Harvard Drug Group) | Lubricating Tears Eye Drops 0.5 oz (15 ml) | Dextran/Hypromellose 0.1%/0.3% | 0536-1282-94 |
| Rite Aid | Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | 11822-9707-5 |
| Rite Aid | Lubricant Eye Drops 10 ml (twin pack) | Propylene Glycol 0.6% | 11822-4811-3 |
| Rite Aid | Gentle Lubricant Gel Eye Drops 15 ml | Hypromellose 0.3%, Glycerin 0.2%, Dextran 70 0.1% | Not provided by the manufacturer |
| Rite Aid | Lubricant Gel Drops 15 ml | Carboxymethylcellulose Sodium 1% | 11822-9706-5 |
| Rite Aid | Lubricating Gel Drops 10 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 11822-4540-3 |
| Rite Aid | Multi-Action Relief Drops 15 ml | Polyvinyl Alcohol 0.5%, Povidone 0.6% and Tetrahydrozoline Hydrochloride 0.05% | 11822-2254-3 |
| Target | Up&Up Dry Eye Relief 15 ml | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 76168-800-30 |
| Target | Up&Up High Performance Lubricant Eye Drops 15 ml (single pack) | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 11673-522-15 |
| Target | Up&Up High Performance Lubricant Eye Drops 15 ml (twin pack) | Carboxymethylcellulose Sodium 0.5% | 11673-522-30 |
| Velocity Pharma LLC | Lubricant Eye Drop 10 ml (triple pack) | Propylene Glycol 0.6% | 76168-502-30 |
| Walmart | Equate Hydration PF Lubricant Eye Drop 10 mL | Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3% | 79903-168-01 |
Original Press Release from September 2023
The U.S. Food and Drug Administration has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. These warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products.
Eye products addressed in the eight warning letters are illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma and others. Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility.
The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Some of these eye products are labeled to contain silver, which may be characterized as silver sulfate, silver sulphate or argentum. Long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray, which is called “argyria.” Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality. When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations,” said Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research. “We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”
The agency issued warning letters to the following companies:
- Boiron Inc.
- CVS Health
- DR Vitamin Solutions
- Natural Ophthalmics, Inc.
- OcluMed LLC
- Similasan AG/Similasan USA
- TRP Company, Inc.
- Walgreens Boots Alliance, Inc.
Consumers currently using eye products included in these warning letters should speak to their health care professional. The FDA encourages consumers and health care professionals to report any adverse reaction to the agency’s MedWatch program.
The FDA has asked the companies to respond within 15 days of receipt of the letters, stating how they will correct the violations. Failure to correct the violations promptly may result in the FDA pursuing legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing an unapproved product. Additionally, the agency has placed some of these companies on import alert to help stop their products from entering the U.S. and reaching consumers.
The FDA’s investigation of eye products is ongoing, and the agency may take additional regulatory or enforcement actions, as warranted.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.