Eye Drops: Recent FDA Warnings and Recalls

The Food and Drug Administration (FDA) has recently issued multiple alerts about eye drops, and some manufacturers have recalled various eye-drop products.[1] Most of the eye drops were nonprescription products designed to alleviate dry or otherwise irritated eyes. Most of the actions were triggered by concerns about faulty production processes that may have resulted in bacterial contamination of certain brands or manufacturing lots (runs). Bacterial contamination of eye drops is especially worrisome because the surface of the eye lacks many of the natural defenses that the skin, gut lining and other body surfaces have. In rare cases, the use of contaminated eye drops has resulted in serious bacterial infections, blindness or death.

Background on chronic dry eyes and treatments

About 7% of U.S. adults have chronic dry eyes. Common symptoms include dryness, redness, irritation, grittiness, burning, foreign-body sensation, excessive tearing, light sensitivity and blurred vision.[2] Among the factors that increase the risk of dry eyes are older age, female sex, use of contact lenses and various medications, and laser surgery. Initial treatment includes applying warm compresses to the eyes, environmental strategies (for example, minimizing wind and dry-heat exposures) and the use of artificial tears, which are available over the counter. Artificial tears generally contain cellulose for viscosity (stickiness), polyethylene glycol or polyvinyl alcohol to reduce evaporation, and preservatives. Gels or ointments are also available; as these higher-viscosity products tend to temporarily blur vision, they are recommended for bedtime use. Preservative-free eye drops are available in more-expensive, single-use formulations.

Allergic conjunctivitis (inflammation of the membranes covering the eyelids and eyeballs) is another common ailment that is treated with over-the-counter eye drops, which sometimes contain antihistamines.[3],[4] Such allergic conditions (triggered by pathogens such as pet dander or pollen) can lead to itching, blurred vision, burning sensations, redness, liquid or crusty discharge from the eye and light sensitivity. Allergic conjunctivitis is not typically associated with pain, so if you experience concerning pain in your eyes you should seek medical attention.

Initial approaches to coping with allergic conjunctivitis include not rubbing your eyes, using cool compresses to reduce edema (swelling), pausing the use of contact lenses, avoiding known allergens and using refrigerated artificial tears.

Recent FDA warnings and manufacturer recalls

In February 2023, the FDA warned consumers not to purchase or use two brands (EzriCare and Delsam Pharma) of artificial tears manufactured by Global Pharma Healthcare Private Limited in India and sold by Walmart and Amazon.[5] The warning was issued after an investigation by the FDA, Centers for Disease Control and Prevention (CDC) and state and local health departments found that the products contained a rare strain of Pseudomonas aeruginosa that is resistant to most antibiotics. The CDC identified the rare bacterial strain in opened bottles of EzriCare Artificial Tears from different manufacturing lots collected in two states. The reported illnesses across 55 patients in 12 states included serious eye infections, respiratory infections, urinary tract infections and sepsis. One patient died from a widespread infection.

In August 2023, the FDA warned consumers not to purchase or use eye drops containing methylsulfonylmethane (MSM) because of concerns about bacterial and fungal contamination. The products were unapproved and illegally marketed; no legally marketed eye drugs contain MSM as an active ingredient.[6]

In September 2023, the FDA sent warning letters to eight companies that they were illegally marketing unapproved eye products to treat such conditions as conjunctivitis (“pink eye”), cataracts and glaucoma.[7] The agency also cited the companies for quality issues that compromised the sterility of the products. The FDA expressed particular concern about products that may harm users; some contained silver, which may permanently change the color of the eye to gray or blue-gray.

In October and November 2023, the FDA warned consumers against the purchase or use of several major brands of eye drops due to concerns about eye infections that could result in partial vision loss or blindness. Some of the products were sold at CVS, Target or Walmart.[8] Subsequently, some of these products were voluntarily recalled by their manufacturer or removed from store shelves and websites.

In January 2024, the FDA warned consumers about fraudulent “copycat” eye-drop products that were unapproved and incomplete reproductions and, in some cases, falsely claimed to treat glaucoma. Samples of some of these products tested positive for bacteria that could result in antibiotic-resistant infection. Although the copycat products were not specifically named in adverse-event reports, consumers reported eye irritation, pain and infection related to “possibly fake Lumify,” the brand of eye drops mimicked by the copycat versions.[9]

In February 2024, following the FDA inspection of a manufacturing facility in India, Brassica Pharma initiated a voluntary national recall of several ointment and lubricant eye products distributed by major retailers including CVS and Walmart.[10] The concern was “lack of sterility assurance at the facility.”

What You Can Do

Given the number of recent FDA warnings and recalls, problems with the bacterial contamination of eye drops may continue. You can protect yourself from unsafe eye drops by taking a few precautions.[11] First, search this FDA database for safety alert information: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts (filter by product type = “Drugs” and look for “eye” products in the resulting date-sorted table). If your product has been the subject of a recall or warning, if the label indicates it has expired or if you are otherwise concerned about product spoilage, do not use the product again and discard it right away. If you cannot access the FDA website, talk to your pharmacist about any concerns you have regarding eye drops.

Additionally, wash your hands well before applying drops to your eyes. Do not touch the open tip of the dispensing container to the surface of your eye or any other surfaces (for example, skin or cloth). Stop using eye drops and consult a clinician if you experience any unusual reactions such as discharge from the eye, pain, redness, blurry vision, light sensitivity, odd sensation or other eye discomfort or dysfunction.[12] Do not use any over-the-counter products that claim to treat glaucoma, cataracts, retinopathy or macular degeneration. Do not use eye-drop products labeled as homeopathic. Do not use eye drops that contain silver sulfate, argentum or MSM.

Report any adverse events you experience while using eye drops to MedWatch, the FDA’s drug-safety reporting program, by visiting http://www.fda.gov/MedWatch or by calling 800-FDA-1088.
 

References

[1] Food and Drug Administration. What you should know about eye drops. https://www.fda.gov/drugs/buying-using-medicine-safely/what-you-should-know-about-eye-drops. Accessed April 2, 2024.

[2] Shtein RM. Dry eye disease. UpToDate. January 2, 2024.

[3] Hamrah P, Dana R. Allergic conjunctivitis: clinical manifestations and diagnosis. UpToDate. March 22, 2024.

[4] Hamrah P, Dana R. Allergic conjunctivitis: management. UpToDate. January 21, 2023.

[5] Worst Pills, Best Pills News. E-alert: FDA issues warning about Ezricare Artificial Tears and Delsam Pharma’s Artificial Tears. February 6, 2023. https://www.worstpills.org/e-alerts/view/141. Accessed April 2, 2024.

[6] Food and Drug Administration. FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination. August 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-methylsulfonylmethane-msm-eye-drops-due. Accessed April 2, 2024.

[7] Food and Drug Administration. FDA issues warning letters to firms marketing unapproved eye products. September 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products. Accessed April 2, 2024.

[8] Food and Drug Administration. FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection. November 15, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye. Accessed April 2, 2024.

[9] Food and Drug Administration. FDA warns consumers of contaminated copycat eye drops. January 1, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-contaminated-copycat-eye-drops. Accessed April 2, 2024.

[10] Food and Drug Administration. Company announcement: Brassica Pharma Pvt. Ltd. issues voluntary nationwide recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment due to potential lack of sterility. February 26, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/brassica-pharma-pvt-ltd-issues-voluntary-nationwide-recall-equate-lubricant-eye-ointment-equate-stye. Accessed April 5, 2024.

[11] Food and Drug Administration. What you should know about eye drops. https://www.fda.gov/drugs/buying-using-medicine-safely/what-you-should-know-about-eye-drops. Accessed April 2, 2024.

[12] Centers for Disease Control and Prevention. Outbreak of extensively drug-resistant Pseudomonas aeruginosa assisted with artificial tears. February 1, 2023. https://emergency.cdc.gov/han/2023/han00485.asp. Accessed April 2, 2024.