25k units of Focus PI eye drops recalled
25,220 units of Focus PI eye drops recalled due to lack of assurance of sterility
750k Sterling Pharma eye drops recalled (multiple brands)
750,000 eye drops recalled by Sterling Pharmaceuticals
40k Bottles of Clear Eyes Maximum Recalled
39k bottles of Clear Eyes Maximum Itchy Eye Relief recalled due to lack of sterility assurance.
12 Million Bottles of Rohto Eye Drops Recalled Due to Lack of Sterility Assurance
12 million bottles of Rohto eye drops and redness relievers recalled due to lack of sterility assurance.
Prednisolone acetate 1% from Lupin recalled
2,530,182 bottles of prednisolone acetate from Lupin Pharmaceuticals recalled
Excelvision Eye Drop Recalls (Multiple Brands)
Genteal Gel, Systane Gel and additional brands manufactured by Excelvision are being recalled.
KC Pharmaceutical Eye Drops Recalled
82 eye drops from 28 brands recalled for sterility reasons
Safety Alert: Do Not Use Lulrsay Preservative Free Saline Solution
The Dry Eye Foundation is warning consumers against using Lulrsay Preservative Free Saline with any contact lenses, including scleral lenses.
How to check the Amazon seller of your eye drops
Are you buying your eye drops from the manufacturer on Amazon or from an unknown reseller? Here’s how to check.
Regener-Eyes Recall Announcement Silent Regarding Unresolved Drug Adulteration Issues
The new MPDF dropper has allowed Regener-Eyes to recall eye drops under the guise of exchanging them for a safer bottle. However, an MDPF dropper will not protect consumers from serious harm due to bacteria or fungus in eye drops prior to first use. Regenerative Processing Plant has been silent regarding its unresolved CGMP violations.
The Dry Eye Foundation continues to recommend against the use of Regener-Eyes Lite and Regener-Eyes Pro, regardless of bottle type or manufacture date.
Regener-Eyes Recall
Regener-Eyes LLC unofficially announced that it was recalling its preservative-free eye drops packaged in a standard bottle without a multi-dose preservative free (MDPF) dropper. Due to the informal nature of the recall, customary recall information that patients need to ensure their own safety was not provided: product names, manufacture dates, lot numbers, expiration dates, and photographs that help identify improperly packaged eye drops.
Open Letter to Key Opinion Leaders
DEF calls on Key Opinion Leaders to partner with the FDA for patient safety.
What you need to know about eye color changing eye drops
Learn more about safety hazards of trending eye drop scams
Safety Alert: Do Not Use Aqua Naina Sterile Saline Solution
The Dry Eye Foundation is warning consumers against using Aqua Naina Sterile Saline Solution with any contact lenses, including scleral lenses.
The FDA Drug Label
What goes into the Drug Facts label on your OTC drops? What claims are manufacturers allowed to make about OTC eye drops, and which ingredients can they use?
FDA Warning: South Moon, Rebright, FivFivGo copycat eye drops contaminated
FDA identifies risks to consumers from copycat eye drops sold on marketplaces like Walmart.com. Learn about DEF’s history of concerns with these products and how you can stay safe.
Regener-Eyes Manufacturer Cited by FDA For Objectionable Conditions and Practices
The manufacturer of Regener-Eyes underwent an FDA drug facility inspection for the first time this year. FDA’s report includes extensive citations for violations, including releasing products for commercial distribution despite failed tests.
Associated Press: After recalls and infections, experts say safer eyedrops will require new FDA powers
Dry Eye Foundation Medical Advisor Dr. Sandra Brown comments on proposed legislation to allow the FDA to perform premarket inspections for OTC eye drop manufacturing facilities.