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What’s going on with OTC eye drops?
Scroll down for all major new FDA warnings since January 2023
August 16, 2024
FDA issues Warning Letter to Regenerative Processing Plant, LLC, manufacturer of Regener-Eyes Lite and Regener-Eyes Pro
FDA’s Warning Letter is a joint communication from the biologics division (CBER) and the drug division (CDER) of the FDA. In addition to declaring Regener-Eyes misbranded and unapproved drugs, FDA cites extensive manufacturing manufacturing violations with serious patient safety implications. Redactions suggest that Regener-Eyes has not complied with FDA’s requests to recall their products.
July 17, 2024
FDA issues Warning Letter to Velocity Pharma LLC, distributor of certain Equate, Rite Aid, CVS, Up&Up, Velocity Pharma, Leader, Rugby, and other brand name eye drop products manufactured by Kilitch Healthcare India
Velocity Pharma LLC was the distributor of Kilitch Healthcare India’s eye drops, which were recalled in November 2023. This letter states that Velocity Pharma did not recall its products until November 15, 2023, approximately three weeks after the FDA recommended products manufactured by Kilitch Healthcare be recalled. The FDA says that Velocity Pharma “failed to take action to remove adulterated products from the market…in sharp contrast to the retailers who took immediate action after notice from FDA that their products are adulterated.”
In this Warning Letter, the FDA states that, as a distributor of Kilitch Pharma drug products, Velocity Pharma LLC 1) failed to ensure the quality of its products and 2) failed to ensure that the products were manufactured in compliance with CGMP before being distributed in the US.
July 11, 2024
FDA issues Warning Letter to Brassica Pharma Pvt. Ltd., citing significant CGMP violations
In February 2024, Brassica Pharma Pvt. Ltd. recalled four ointments sold in the US. This warning letter from July 11 details the finding’s of the FDA’s inspection in January 2024. Highlights from the letter include: failure to test every batch for sterility, data falsification, failure to establish and follow appropriate procedures to prevent microbiological contamination and to validate aseptic and sterilization processes, deficiencies that compromise the ability to maintain aseptic conditions, and inadequate cleaning of aseptic processing lines. Following the February recall, the FDA asked Brassica Pharma whether they will resume manufacture of drugs for the US market.
June 20, 2024
FDA Issues warning letter to Optikem International
Brands/Products: FDA does not list the products in the Warning Letter, but cites “over-the-counter and homeopathic ophthalmic drug products” and Dry Eye Foundation has verified that at least two TRP brand homeopathic eye drops were manufactured there.
March 28, 2024
FDA Issues Warning Letter to Kilitch Healthcare India Limited citing “egregious violations”
See FDA issues Public Warning about 28 eye drops sold under 7 brands.
FDA cites insanitary conditions, CGMP violations, failure to collect samples, data integrity issues, environmental monitoring deficiencies, facility maintenance deficiencies, failure of Quality Unit to execute its responsibilities, and and ineffective quality system. According to the Warning Letter, Kilitch took approximately three weeks to issue a voluntary recall of its products after the FDA shared their inspection found insanitary conditions and other “egregious violations.”
February 27, 2024
FDA issues Warning Letter to Amman Pharmaceutical Industries over extensive OTC ophthalmic drugs (recalls anticipated)
Brands/Products: FDA does not list the products in the Warning Letter, but Dry Eye Foundation has determined that they include TRP (“The Relief Products”) brand eye drops as well as other brands.
According to the Warning Letter, the company will “recall all drug products and suspend production of all drugs for the U.S. market.
February 27, 2024
FDA issues warning letter to LightEyez for more than 10 Eye Drops due to “Gross Microbial Contamination”
LightEyez makes (among other things) many eye drops that claim to change one’s eye color. Dry Eye Foundation reported this UK-based company to FDA in June, 2023.
FDA tested one or more of their products and engaged in dialogue with the company. According to the Warning Letter, in August 2023 the company promised to recall their products, but didn’t and then stopped responding to the FDA.
February 26, 2024
Nationwide recall of 4 eye ointments due to potential lack of sterility
Brands/Products: Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, AACE Lubricant PM Ointment
January 31, 2024
FDA warns about 3 Bausch & Lomb Lumify “copycat” products: South Moon, Rebright, Fivfivgo due to contamination risks
FDA warns consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of the potential risk of eye infection. These unapproved products are designed to copycat Bausch and Lomb’s Lumify Redness Relieving Drops. The FDA found one brand, South Moon, to be contaminated with Burkholderia cepacia complex.
The Dry Eye Foundation reported these drops to the FDA in 2023 after discovering them for sale on Walmart.com and other ecommerce sites.
The origin of these products is currently unknown to the FDA. While the FDA has not received any adverse event reports related to these product names, the agency has received complaints related to possibly fake Lumify, including product quality concerns, eye irritation, pain and infection.
December 15, 2023
Regener-Eyes manufacturer cited by FDA for extensive violations
Brand/Products: Regener-Eyes Lite, Regener-Eyes Pro
Dry Eye Foundation obtained the FDA’s inspection report through a FOIA request.
December 1, 2023
FDA issues Warning Letter to Belmont Eyecare LLC regarding 6 eye drops
Brand/Products: Ashland Eye Care Colloidal Silver Eye Drops, MSM Eye Drops, Organic Daytime Oil Eye Drops, and Organic Evening Oil Eye Drops.
November 14, 2023
FDA issues Warning Letter to Amazon.com regarding 7 products
Products: Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops, OcluMed Eye Drops, TRP Natural Eye Floaters Relief, Manzanilla Sophia Chamomile Herbal Eye Drops
FDA reported Can-C, Optique 1, OcluMed and Manzanilla to FDA in 2023.
See also September 12, 2023 notice.
November 14, 2023
FDA issues Warning Letter to Global Pharma regarding 3 products
Brands/Products: EZRICARE Artificial Tears, Delsam Pharma’s ARTIFICIAL TEARS, and Delsam Pharma’s ARTIFICIAL EYE OINTMENT
This warning letter is a follow-up from the FDA’s inspection of Global Pharma in February/March after the tragic outbreak of Pseudomonas aeruginosa infections. Among other things, this letter provides the first public confirmation that Pseudomonas aeruginosa was found in intact bottles of the Artificial Tears products manufactured by Global Pharma.
November 1, 2023
Nationwide recall, 2 Rugby Products, due to potential risk of eye infections
Products: Rugby brand Polyvinyl Alcohol 1.4%; Dextran/Hypromellose, 0.1%/0.3%
November 1, 2023
Nationwide recall, 6 eye erops, due to potential eye infections
Brand/Products: Leader brand Eye Irritation Relief, Dry Eye Relief (CMC 1%), Lubricant Eye Drops (single and twin packs), Dry Eye Relief (Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3%), Lubricant Eye Drops (Propylene Glycol, 0.6%)
October 30, 2023
FDA issues Warning Letter to Dexterity Health re: MSM Drops
Brand/Product: Dexterity Health Liquid MSM Drops
Dry Eye Foundation reported this product to FDA in June 2023.
October 27, 2023
FDA issues Public Warning about 28 eye erops sold under 7 brands
CVS Health - 9 products
Rugby (Cardinal Health) - 2 products
Leader (Cardinal Health) - 5 products
Rite Aid - 6 products
Target Up&Up - 3 products
Velocity Pharma - 1 product
Walmart Equate - 1 product
September 12, 2023
FDA issues Warning Letters to 8 companies about 38 eye drops
As part of increased enforcement action on over-the-counter drug manufacturing and marketing violations, FDA issued a news release about the publication of Warning Letters sent to 8 more companies about a total of 38 products. Violations included manufacturing facility violations, failure to seek drug approval, and making drug product claims, among others.
Similasan AG (12 Similasan brand products)
TRP Company Inc (10 Natural Eyes brand products)
Walgreens Boots Alliance, Inc. (3 Walgreens brand products - Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops, Walgreens Pink Eye Drops)
Natural Ophthalmics, Inc (6 Natural Ophthalmics brand products)
CVS Health (1 CVS brand product - CVS Health Pink Eye Relief Drops)
Boiron SA (1 product - Optique 1 Eye Drops)
DR Vitamin Solutions (4 products - Can-C Eye Drops, Life Extension Brite Eyes III, Longevity Science Visual Ocuity, Vision Clarity Eye Drops)
OcluMed LLC (1 product - OcluMed Eye Drop)
August 30, 2023
Nationwide recall of 2 eye drops due to bacterial and fungal contamination
Brand/Products: Dr. Berne’s MSM Drops 5% and 15% Solution Eye Drops
August 22, 2023
Consumers warned not to purchase or use certain MSM eye drops due to contamination
Brands/Products: Dr. Berne’s MSM Drops 5%, LightEyez MSM Eye Drops - Eye Repair
April 30, 2023
Public Safety Notification on Amniotic Fluid Eye Drops
Brands/Products: Regener-Eyes Lite, Regener-Eyes PRO and StimulEyes
This notification is in relation to Regener-Eyes and StimulEyes. StimulEyes was removed from the market by its distributor shortly this notice was published by the FDA.
March 3, 2023
Worldwide recall (1 eye drop) due to non-sterility
Brand/Product: Purely Soothing 15% MSM Drops
February 2, 2023
Nationwide recall (3 products) due to possible contamination
Brands/Products: EzriCare Artificial Tears, Delsam Pharma Artificial Tears, Delsam Pharma Artificial Eye Ointment
Shortly after the CDC issued a Health Advisory about treatment-resistant infections linked to EzriCare Artificial Tears, Global Pharma announced the recall of these two identical artificial tear products. CDC later published an update stating that as of May 15, 4 patients had died, 14 experienced vision loss and an additional 4 had to have enucleation (surgical removal of an eyeball).