Lubricant Eye Drops Under Class II Recall for Sterility Concerns
Key Takeaways
- The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class II recall of FRESHKOTE Lubricant Eye Drops (10 mL), involving 50 900 units distributed nationwide and identified as Lot #1X68 and 1X69 (Exp. 05/31/2027).
- The recall was initiated by Harrow Eye LLC due to lack of assurance of sterility, a quality issue that may lead to temporary or medically reversible adverse health effects.
- FRESHKOTE lubricant eye drops are indicated for the relief of dry eye symptoms by lubricating the ocular surface, commonly used in outpatient and retail settings.
The FDA has classified a Class II recall for FRESHKOTE Lubricant Eye Drops, a sterile ophthalmic solution supplied in 0.33 fl oz (10 mL) bottles. The product is manufactured and distributed by Harrow Eye LLC, based in Nashville, Tennessee. The recall affects 50 900 units distributed nationwide in the US, specifically Lot #1X68 and 1X69, with an expiration date of May 31, 2027. The recall was initiated on April 17, 2026.
The recall was prompted by lack of assurance of sterility, a critical concern for ophthalmic products that come into direct contact with the eye. Although no contamination has been confirmed, compromised sterility may increase the risk of eye irritation, infection, or other adverse ocular effects. The FDA classified the recall as Class II on April 23, 2026, indicating that use of the affected product may cause temporary or medically reversible adverse health consequences, with a low likelihood of serious harm. Harrow Eye LLC notified consignees via letter; no public press release has been issued.
FRESHKOTE Lubricant Eye Drops are indicated for the relief of dry eye symptoms, helping to moisturize and protect the ocular surface. These products are widely used in outpatient, retail, and ophthalmology settings. Pharmacists should identify and remove affected lots from inventory, advise patients to discontinue use of impacted bottles, and recommend alternative sterile ophthalmic lubricants.
Reference
FDA. Enforcement Report. May 7, 2026. Accessed May 7, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
