Eye drops Recall: FreshKOTE Lubricant Eyedrops 0.33 oz
Announced 2026-04-29 · FDA
The FDA is recalling FreshKOTE Lubricant Eyedrops due to lack of assurance of sterility. The recall covers about 50,900 units distributed nationwide in the United States. Recalled lots are 1X68 and 1X69, with expiration date 05/31/2027.
| Brand | Harrow Eye LLC |
|---|---|
| Product | FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA. |
| Reason | Lack of Assurance of Sterility |
| Severity | moderate |
| Units affected | 50900 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use this product.
- Check the lot number on your bottle and the expiration date; if it shows 1X68 or 1X69 or expires 05/31/2027, discontinue use immediately.
- Dispose of the product according to local guidelines or return it to the place of purchase; contact Harrow Eye for replacement or refund instructions.
- If you have used the product and have health concerns, consult your healthcare provider.
How to identify the recalled item
| Lot / date codes | Lot #: 1X68, 1X69, Exp. Date 05/31/2027. |
|---|---|
| Lot / date codes | Lot #: 1X68, 1X69, Exp. Date 05/31/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.