Excelvision Eye Drop Recalls (Multiple Brands)
FDA has requested companies whose eye drops were made at Excelvision (a contract manufacturer in France) to recall unexpired lots of eye drops produced at this facility due to adverse inspection findings.
Some of the products affected by this recall are no longer manufactured by Excelvision. The distributors involved transferred their products to a different manufacturing company in 2025 or earlier.
On this page:
FAQ
Recall details (including lot numbers and links to relevant FDA pages, where available)
Information about Excelvision
FAQ
Which specific products are (or are not) being recalled for each brand?
Only products currently or formerly manufactured by Excelvision are being recalled:
Systane brand
RECALLED: Systane Night Gel
NOT RECALLED: Systane Ointment, Systane Gel Drops, Systane Original, Systane Ultra, Systane Hydration, Systane Balance, Systane Complete, Systane Pro. These products are not made at Excelvision.
Genteal brand
RECALLED: Genteal Tears Severe Gel
NOT RECALLED: Genteal Tears Ointment, Genteal Tears Moderate. These products are not made at Excelvision.
Optase brand
RECALLED: Optase Dry Eye Intense (bottles only, certain lots only)
This product is no longer made at Excelvision.
NOT RECALLED: Any Optase Dry Eye Intense with a lot number beginning in 200, i.e. manufactured at a different facility, Optase MGD, Optase Hylo Relief, Optase Hylo Night, Optase Hylo Forte, Optase Dry Eye Spray. These products are not made at Excelvision.
Oasis brand
RECALLED: Oasis Tears PF (bottles only, small number of lots all expiring in 2026) This product has not been manufactured at Excelvision since 2024.
NOT RECALLED: Any Oasis Tears PF bottles with a lot number beginning in 100, i.e. manufactured at a different facility, Oasis Tears PF single-use vials, Oasis Tears (preserved bottles), Oasis Tears Plus PF bottles, Oasis Tears Plus PF single-use vials
Ivizia brand
RECALLED: Ivizia Lubricant Eye drops (bottles only, small number of lots all expiring in 2026). This product has not been manufactured by Excelvision since 2023.
NOT RECALLED: Ivizia Severe Gel (single-use vials). This product is not made at Excelvision.
Freshkote brand
RECALLED:: All unexpired lots
What can I use instead of the recalled products?
Consult your eye care professional for a recommendation. We offer information here on similar products for reference only.
Alternatives to recalled Genteal Gel, Systane Gel: Unfortunately, there are no equivalent products on the market (i.e. gels in tubes).
Potential alternatives include lubricant eye ointments (e.g. Genteal Ointment, Systane Ointment, Refresh PM, Optase Hylo Night, Soothe PM) and preservative-free gels (Ivizia Severe Gel or Refresh Celluvisc).
Alternative to recalled Optase Dry Eye Intense: You can purchase Optase DEI bottles that are not affected by the recalls as the manufacturing has been transferred to another company. You can also purchase Optase DEI in single-use vials, which were not manufactured by Excelvision.
Alternatives to recalled Oasis Tears: You can purchase Oasis Tears PF bottles that are not affected by the recalls as the manufacturing has been transferred to another company. You can also purchase Oasis Tears PF in single-use vials, which were not manufactured by Excelvision.
Alternatives to recalled Ivizia drops: You can purchase Ivizia drops that are not affected by the recalls, as the manufacturing was transferred to another company more than two years ago.
Recall details
Retail-level recalls are currently being conducted for the following products:
Genteal Tears Lubricant Eye Gel
All unexpired lots
This recall applies ONLY to the gel - not to Genteal Ointment or any other Genteal brand eye drops
Recalled lots:
9T20, 9T50, 9T59, 1U30, 1U48 exp. 4/30/2026
L4V15, exp. 8/31/2026
7V61, exp. 12/31/2026
1W47, 1W49, 1X14 exp. 3/31/2027
All unexpired lots
This recall applies ONLY to the gel - not to Systane Ointment or any other Systane brand eye drops
Recalled lots
Lot 9T21, exp. 4/30/2026
Lots 1U63, 2U47, exp. 5/31/2026
Lots 6V00, 6V12, 8V54, exp. 1/31/2027
Lots 9V55, 8V58, 9V39, 9V97, exp. 2/28/2027
Lot 1W39, 1W40, exp. 3/31/2027
Lot 1X76, exp. 4/30/2027
Optase Dry Eye Intense (multi-dose preservative-free bottle version only)
This applies only to Optase Dry Eye Intense multi-dose preservative-free bottles only. It does not apply to Optase DEI in single-use vials or to any other Optase brand eye drop.
Recalled lots:
Lots 8T98, 9T31, 9T32 exp. 4/30/2026
Lots 2V13, 2V14, 2V15 exp. 6/30/2026
Lots 3V35 exp. 8/31/2026
Lots 3V36, 3V37 exp. 9/30/2026
Lots 5V45, 5V46, 9V12 exp. 3/31/27
Lots 1X57, 1X70, 1X84 exp. 5/31/27
Ivizia Eye Drops (multi-dose preservative-free bottle version only)
This applies to Ivizia Eye Drops in multi-dose preservative-free bottles only. It does not apply to Ivizia Severe/Night Gel Drops in individual vials.
Recalled lots:
NDC 59262-700-11
Lots 5S30B, 5S30C exp. 4/30/2026
Lots 5S31B, 6S57B expiring 5/31/2026
NDC 82584-700-11
Lot 3T36B expiring 10/31/2026
Oasis Tears PF (multi-dose preservative-free bottle version only)
Recalled lots:
Lot 1V59 exp. 5/31/2026
Lots 3V69, 3V12 exp. 8/31/2026
Recall does not apply to Oasis Tears single use vials or to any other Oasis brand eye drops. All Oasis brand eye drops are made at a different facility now.
Waiting for FDA link
Freshkote (multi-dose preservative-free bottle)
NDC 82667-0130-10
Recalled lots: All unexpired
1X68 Exp. 5/31/2027
1X69 Exp. 5/31/2027
Additional recalls?
We are aware of one other OTC product that might be subject to recall based on the manufacturing location of record.
It is unclear whether any prescription drugs will be recalled.
Scope Health recall announcement (click to download full notice)
Alcon recall announcement (click to download)
Oasis Medical Announcement (click to download full notice)
Why are these eye drops being recalled?
All of these eye drops were or are manufactured by Excelvision, a contract manufacturing facility in France.
FDA inspections in 2024 and 2025 revealed manufacturing violations that may affect product quality.
Who is Excelvision?
Excelvision is a contract manufacturing facility in France which makes (or made) several name-brand eye drops sold in the US.
In the past two years, FDA has taken enforcement actions against Excel for manufacturing violations. These violations include failing to follow procedures designed to prevent microbiological contamination and failing to properly investigate customer complaints.
Timeline:
November 2024: FDA inspects Excelvision and identifies serious manufacturing violations. Read full Inspection Report (FDA Form 483).
2024 to 2025: Some companies transfer their eye drops to other manufacturing facilities
May 2025: FDA publishes its official Warning Letter, making details of Excel's violations public. Like most FDA Warning Letters to manufacturers, this letter was sent after the company was given the opportunity to correct the problems and their response was deemed inadequate.
January 2026: FDA re-inspects Excelvision resulting in 11 citations for procedural violations, 6 of which were related to aseptic processing and prevention of microbiological contamination.
April 2026: FDA has reportedly asked 6 companies distributing eye drops in the US to recall eye drops manufactured by Excel "to the retail level", meaning consumers do not have to be notified. Read full Inspection Report (FDA Form 483).
April 2026: FDA places Excel Vision on import alert. (Search page for “Excel Vision” for details)
