U.S. Recall.

As an ophthalmologist, I want to make patients aware of a recent U.S. recall of over 3 million bottles of  GENERIC over-the-counter eye drops sold at major chains such as CVS and Walgreens. 

What’s the issue?

• The recall is due to a “lack of assurance of sterility” during manufacturing. 
• This means the drops may not be sterile, and therefore could potentially introduce infection into the eye. 
• Importantly, no confirmed contamination or infections have been reported with this specific recall. 
• There are no recalls on BRAND NAME drops such as Refresh, Systane, Hylo, Blink etc
• There are no recalls on PRESCRIPTION drops

How serious is this?

• The FDA has classified this as a Class II recall, meaning:
  • Risk of harm is low
  • Any adverse effects would likely be temporary or reversible

Who should be concerned?

• Patients who have:
  • Recently travelled to the U.S.
  • Purchased store-brand or generic eye drops (especially artificial tears or redness relief)
• These products were widely distributed under multiple labels, not just a single brand. 

What should you do?

• If you have eye drops purchased in the U.S.:
  • Stop using them until verified safe
  • Check lot numbers (many begin with codes like AC, AR, LT, etc.)
• Seek care urgently if you develop:
  • Increasing redness
  • Pain
  • Discharge
  • Light sensitivity
  • Vision changes

Canadian context

• This recall is specific to the United States
• There have been no reported cases or recalls of this type in Canada related to this event