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.

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.
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
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.