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OTC Eye Drop Warnings & Recalls

Review FDA Notices 2022 to present

Scroll down for year-by-year synopsis of FDA activity

2025 to date

FDA Warning Letters, Recalls and other public notices

Last updated 9/23/2025. Click here for details.

  • 8/25: FDA Warning Letter to Life Enthusiast Co-Op (distributor in NV) regarding Amazing Collyrio, Fulvic Eyes, MSM Gold Drops

  • 8/25: FDA Warning Letter to Homepathic Family Medicine (distributor in CA) regarding Cineraria Maritima Eye Drops

  • 8/25: FDA Warning Letter to Trew Balance (distributor in AZ) regarding Trew Vision CBD Eye Drops

  • 8/25: FDA Warning Letter to Supply Center USA (distributor in WY) regarding 7 Similasan Brand eye drops and 1 Boiron Optique brand homeopathic eye drops, which were also the subject of enforcement activity in 2023

  • 8/25: FDA Warning Letters to “My Holistic Honey” (distributor in CA), Green Vitality (GA) and Mel Honey US (UT) regarding Jimerito Honey eye Drops

  • 7/9: FDA Warning Letter to EyeTech One (distributor in FL) regarding Eyelivio Nighttime Eye Ointment

  • 7/9: FDA Warning Letter to Scope Health (distributor in NY for UK based company) regarding OTC eye drop, eye ointment and lid care products. NOTE: The violations in question appear to relate exclusively to marketing violations which have since been corrected.

  • 7/9: FDA Warning Letter to Revitalize Energy (distributor in PA) regarding Revitalize Energizing Eye Drops

  • 7/9: FDA Warning Letter to Covalent Medical (distributor in VA) regarding Focus PI Eye Drops

  • 5/15: 6 lots of Nutrifill scleral filling solution recalled by Contamac (distributor in CO for UK based company) due to customer infections and corneal ulcers (Update Sept 23: Adverse events have been reported for 46 individual patients. Click for details.)

  • 5/13: FDA Warning Letter to AACE (manufacturer/distributor in NJ) regarding lubricant eye ointment

  • 5/8: Recall to retail level [no FDA announcement] for 5 AvKare brand generic eye drops and gel

  • 5/7: FDA Warning Letter to Excelvision Fareva (manufacturer in France) over longstanding mold problems and failure to address customer complaints

  • 4/23: FDA Warning Letter to OSRX (compounding pharmacy in Missoula, MT) over unsanitary conditions and labeling failures

  • 3/4: FDA Warning Letter to C&N Naturistics (distributor in CA) regarding two eye drops

  • 2/24: FDA Warning Letter to Aspen Pharmacare (manufacturer in Durban, South Africa)

2024 Issues

  • 12/23: Recall notice from Alcon for one lot of Systane Ultra (single use vials) due to fungal contamination

  • 12/3 and 12/20: Information communications from Regener-Eyes regarding a product recall to the consumer level which they failed to conduct according to protocol. On December 3rd, Regener-Eyes LLC first communicated about this in a press release. On December 20th, American Optometric Association shared further details including a recall form on the Regener-Eyes website. No formal announcement has been issued on the FDA website as yet. Please read Dry Eye Foundation statement about this recall.

  • 10/24 FDA Warning Letter to Fancy Drops Beauty LLC regarding 10 eye color changing eye drops.

  • 10/2: FDA Warning Letter to Omni Lens, manufacturer of Vista Gonio Eye Lubricant

  • 8/16: FDA 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. These products were previously subject to a Public Safety Notification (2023) and Untitled Letter (2022).

  • 7/17: FDA Warning Letter to Velocity Pharma (distributor in Melville NY) regarding products which have been recalled; the products included CVS, Rite Aid, Target Up & Up, Rugby and other brands.

  • 7/11: FDA Warning Letter to Brassica Pharma (manufacturer in India), whose products have been recalled.

  • 6/20: FDA Warning Letter to Optikem International (manufacturer in Denver, CO) over extensive CGMP violations for homeopathic drugs. DEF verified that at least two TRP brand products were manufactured there.

  • 3/28: FDA Warning Letter to Killitch (manufacturer in India) over egregious manufacturing violations of generic eye drops.

  • 2/22: Recall Notice for 4 eye ointments (Walmart/Equate, CVS and AACE brands) by Brassica Pharma due to lack of sterility

  • 2/15: Warning Letter to LightEyez Limited (distributor in London, UK) regarding eye color changing and MSM eye drops, due to “gross microbial contamination”. One of these was previously subject to a Public Warning in 2023.

  • 2/14: FDA Warning Letter to Amman Pharmaceuticals (manufacturer in Amman, Jordan) regarding extensive CGMP violations of eye drops. Letter states they will be recalled.

  • 2/13: FDA Warning Letter to Ezricare LLC (distributor in Lakewood NJ) regarding products recalled in 2023.

  • 2/13: FDA Warning Letter to Delsam Pharma (distributor in Mamaroneck, NY) regarding products recalled in 2023.

  • 1/31: Public Warning about eye drop brands South Moon, Rebright and Fivfivgo, which are copycats of Bausch & Lomb products, due to contamination risks.

  • 1/19: Recall Amendment for 2 Rite Aid lubricant drops recalled by Killitch.

2023 Issues

  • 12/15: Inspection report for Regenerative Processing Plant (manufacturer in Palm Harbor, FL) obtained by DEF through FOIA request. Inspection results cite the company for extensive manufacturing violations in relation to Regener-Eyes brand products

  • 12/5: FDA Warning Letter to Belmost Eyecare (distributor in Chicago, IL) regarding colloidal silver, MSM and other eye drops

  • 11/28: FDA Warning letter to Dr. Berne’s regarding previously recalled MSM eye drops

  • 11/15: Recall Notice from Killitch Healthcare (manufacturer in India) for 27 eye drops distributed under Rugby, Leader and other brand names

  • 11/14: FDA Warning Letter to Amazon (distributor, Seattle WA) for distribution of 7 eye drops, some of which are also named in other distributor Warning Letters

  • 11/14: FDA Warning Letter to Global Pharma (manufacturer in India) regarding manufacture of previously recalled eye drops and ointment.

  • 11/1: Recall Notice from The Harvard Drug Group for Rugby brand eye drops due to risk of infection. Overlaps with Killitch recall.

  • 11/1: Recall Notice from Cardinal Health for 5 eye drops (overlaps with Killitch recall).

  • 10/27: FDA Public Warning regarding 27 eye drops including CVS, Leader, Rugby, Rite Aid, Target Up & Up and Velocity Pharma brands. This notice was apparently posted due to Killitch’s delay in issuing a recall for these products.

  • 9/11: FDA Warning letter to TRP (distributor in Reno NV) regarding unapproved homeopathic eye drops.

  • 9/11: FDA Warning Letter to Natural Ophthalmics (distributor in CO) regarding unapproved homeopathic eye drops.

  • 9/11: FDA Warning Letter to CVS Health (distributor in RI) regarding unapproved homeopathic eye drops.

  • 9/11: FDA Warning Letter to Boiron, Inc (distributor in PA) regarding unapproved homeopathic eye drops.

  • 9/11: FDA Warning Letter to Dr. Vitamins LLC (distributor in TX) regarding unapproved homeopathic eye drops.

  • 9/11: FDA Warning Letter to Similasan (manufacturer in Samen, Switzerland) regarding manufacturing violations and unlawful distribution of homeopathic products.

  • 9/11: FDA Warning Letter to Walgreens (distributor in IL) regarding unapproved homeopathic eye drops.

  • 9/11: FDA Warning Letter to OcluMed (distributor in PA) regarding distribution of unapproved eye drops.

  • 8/30: Recall Notice by Sam Berne’s for MSM eye drop products.

  • 8/22: Public Warning regarding LightEyez (distributor in London, UK) MSM Eye Drops due to contamination.

  • 6/13: Recall (no public notice) by KC Pharmaceuticals of 9 eye drops

  • 6/13 Recall (no public notice) by KC Pharmaceuticals of 17 eye drops

  • 4/28: FDA Warning Letter to Pharmedica (manufacturer in AZ) regarding MSM eye drops.

  • 4/10: Public Safety Notification regarding amniotic fluid eye drops from Regener-Eyes (Regener-Eyes Lite, Pro) and M2 Biologics (StimulEyes).

  • 3/3: Recall Notice from Pharmedica (manufacturer in AZ) for MSM eye drops due to non sterility.

  • 2/24: Recall Notice from Global Pharma for Delsam Pharma Artificial Eye Ointment.

  • 2/2: Recall Notice from Global Pharma for Ezricare and Delsam Pharma Artificial Tears.