Excelvision Eye Drop Recalls

Details for April 2026 recalls of eye drops made by Excelvision.

Updated on
Excelvision Eye Drop Recalls

This is an evolving situation. The blog post is being updated each time additional recalls are announced. For more information, see nonprofit site eyedropsafety.org.

4/27/26 update - added links to FDA site for Genteal Gel / Systane Gel

About Excelvision

Excelvision is a contract manufacturing facility in France which makes (or made) many 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 dismissing customer complaints about mold and blaming the incidents on the customers, when in fact the manufacturing facility had evidence of mold and other contamination hazards in critical areas.

What happened

Nov 2024 FDA inspects Excelvision and identifies serious manufacturing violations.
2024 - 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.
Jan 2026 FDA re-inspects Excelvision
Apr 2026 FDA reportedly asks 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.

 

Active recalls of eye drops manufactured by Excelvision

Optase Dry Eye Intense, multi-dose preservative-free bottle only

Contact information: Scope Health, 917-795-4227

  • Retail level recall
  • Single-use vials are not affected by this recall
  • No other Optase brand products are affected by this recall.
  • Only the lots of Optase DEI that were manufactured at Excelvision are on recall. Scope transferred Optase DEI to a different manufacturing facility in 2025. Any product with a batch number that begins with 200 is not part of this recall as they were made by the new manufacturer after the transfer.
 Lot Expiration
8T98, 9T31, 9T32 April 30, 2026
2V13, 2V14, 2V15 June 30, 2026
3V35 August 31, 2026
3V36, 3V37 September 30, 2026
5V45, 5V46, 9V12 March 31, 2027
1X57, 1X70, 1X84 May 31, 2027

 

GenTeal Tears Severe Gel (NDC 0065-8064-01)

  • Contact information: Alcon, 800-757-9195.
  • All unexpired lots are subject to recall.
  • This recall pertains only to the gel, not the ointment.
 Lot Expiration
9T20, 9T50, 9T59, 1U30, 1U48 4/30/2026
4V15 8/31/2026
7V61 12/31/2026
1W47, 1W49, 1X14 3/31/2027


Systane Night Gel (NDC 0065-0474-01)

  • Contact information: Alcon, 800-757-9195.
  • All unexpired lots are subject to recall.
  • This recall pertains only to the gel, not the ointment or gel drops.
Lot Expiration

9T21

4/30/2026

1U63, 2U47

5/31/2026

6V00, 6V12, 8V54

1/31/2027

9V55, 8V58, 9V39, 9V97

2/28/2027

1W39, 1W40

3/31/2027

1X76

4/30/2027

 

Additional recalls that are expected

Oasis Tears, multi-dose preservative-free bottle only

Please contact Oasis Medical with questions or concerns at 844-820-8940.

  • 3 lots manufactured in 2024 and expiring no later than August 2024, lot numbers TBA. 
  • Oasis Tears Plus NOT affected by this recall
  • Unit dose vials NOT affected by this recall
  • Oasis transferred manufacturing of this product to a different facility in 2024 due to their concerns about Excelvision. Only lots manufactured prior to the transfer are on recall.

Ivizia Lubricant Eye Drops, multi-dose preservative-free bottle only

Please contact Thea Pharma with questions or concerns at 1-800-240-9780 (Option 6).

  • We are awaiting lot and expiration information, but it is expected to be only lots manufactured in 2023 therefore very near their expiration
  • Ivizia Severe Gel is not part of the recall
  • All Ivizia brand eye drop manufacturing was transferred from Excel to another manufacturing facility at least two years ago

Freshkote 

The company confirmed that a recall is taking place. We have requested details.

Eyeleve MGD [UNCONFIRMED]

Based on public records, Eyeleve MGD has a history of being manufactured by Excelvision. We are waiting for the company to confirm.

Refunds, credits, replacements

If you purchased products from the Dry Eye Shop which are now on this recall list and they are still unused:

  • We can replace the products for you, if we have them in stock (assumes only products no longer manufactured by Excelvision)
  • We can refund the products for you, as long as your purchase occurred no longer than one year ago; or
  • We can provide an in-store credit.

Please send photo showing the lot and expiration as well as your details to service@dryeyeshop.com or call us at 877-693-7939 for assistance.

If you purchased the products elsewhere, please contact the company you purchased them from, or the manufacturer.

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1 comment

Any recalls or negative reactions on the Optase nighttime gel? I haven’t begun using it and want to be sure it’s safe.

Your prompt reply is greatly appreciated.

Letty Roerig

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