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.  

DEF calls on Key Opinion Leaders to partner with the FDA for patient safety.

Learn more about safety hazards of trending eye drop scams

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.

“Eyedrops pulled from pharmacy shelves around the US last month were made in an unsanitary factory in India where workers went barefoot and made up test results so the products appeared to be safe, according to a US government report.”

Latest information on warnings and recalls of Velocity Pharma eye drops sold under brands CVS, Leader, Rugby, Rite Aid, Target Up & Up, Walmart Equate and Velocity Pharma.

Infographic about “Are My Eye Drops Safe?” with QR code for quick access to database

Dr. Brown’s commentary on a Warning Letter sent by the FDA to K.C. Pharmaceuticals, a large manufacturer of private-label eye drops sold in the US.

Six months, seven manufacturers, eleven products: It’s been an unprecedented year for eye drop recalls and FDA warnings.

“The American public should know that nobody’s looking. It’s not the FDA’s fault that they don’t have the resources to do this. But they shouldn’t pretend that they can”

FDA says they do not approve or review over-the-counter eye drops - but what does this mean? And, is anybody inspecting the factories where OTC drops are made?

The Dry Eye Foundation reported 205 eye drops to the FDA that were not found in the FDA database.

Includes recommendations from Dr. Brown for patients and doctors who have concerns

Surge of unregulated eye drops continues on popular e-commerce websites

Since April 2022, the Dry Eye Foundation has been voicing concerns over the packaging of preservative-free drops as well as availability of noncompliant drops at online retailers.

DrB addresses five misconceptions about biological eye drops and FDA approval, clinical trials, sterility, and regulatory rules.

From ingredients that should not be included to ingredients that should be but are not, and improper storage and manufacturing, numerous eye drops have raised safety concerns.

More than 50 “red flag” eye drops found on popular e-commerce marketplaces