Excelvision Eye Drop Recalls

Details for April 2026 recalls of eye drops made by Excelvision. 6 brands affected.

Updated on
Excelvision Eye Drop Recalls

For more information on these recalls, and to look up any eye drop for safety flags, see nonprofit site eyedropsafety.org.

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 years 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 OTC eye drops in the US to recall eye drops manufactured by Excel "to the retail level", meaning consumers do not have to be notified.

We have reason to believe prescription eye drops manufactured by Excelvision may also be recalled.

 

Active recalls of OTC eye drops manufactured by Excelvision

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.
 Recalled lots Expirations
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.
Recalled lots Expirations

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

 

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.
 Recalled lots Expirations
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

 

Ivizia Lubricant Eye drops, multi-dose preservative-free bottle only (NDC 59262-700-11 and 82584-700-11

  • Contact information: Thea, 1-800-240-9780 (Option 6).
  • 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
  • None of these lots were distributed by Dry Eye Shop
 Recalled lots Expirations
5S30B*, 5S30C* April 30, 2026
5S31B*, 6S57B* May 31, 2026
3T36B October 31, 2026 

*These four lots have the name Similasan on the box in addition to Ivizia.

Oasis Tears, multi-dose preservative-free bottle only (NDC 42126-6400-1)

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

  • 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.
  • Any lots with a format starting with 100 are from the new contract manufacturer.
 Recalled lots Expirations
1V59 May 31, 2026
3V12, 3V69 August 31, 2026

 

Freshkote 

Please contact Harrow with questions or concerns at 615-733-4330.

 Recalled lots Expirations

1X68, 1X69

(all unexpired lots)

5/31/2027

We did not sell any of the expired lots of Freshkote at Dry Eye Shop - we discontinued the product prior to the manufacture date of the recalled lots due to our own concerns about Excel Vision.

Possible? One more brand

Based on public records, one other eyedrop brand is manufactured by Excelvision. We reached out to the US distributor, who stated that it is not on recall. We are hoping for further clarifying information. We have not ever sold this product at Dry Eye Shop.

Replacements, refunds, credits

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

  • We can replace the products for you, if we have them in stock (this pertains to products no longer manufactured by Excelvision and for which we have new stock)
  • 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 for purchased longer than one year ago.

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.

Updated on

3 comments

Hi Ilene and Letty! We have reached out about your questions above via email but I wanted to post here as well in case any other people were wondering. Optase Nighttime Gel, Ivizia Gel and Systane PF Complete are not part of this recall.

Brenda

Ivizia Gel in individual vials is my nightly go to. And Systane PF Complete. I assume they are both OK??? Do tell. Prompt response grateful

Ilene

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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