PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Summary
The FDA issued a Class II for PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye by PReye LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0621-2026
Action Date
2026-07-01
Status
Ongoing
Category
drug
Product Description
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Lot/Code Info: All lots within expiry
Quantity Affected: approximate 50 to 60 bottles
Reason for Recall
Lack of Assurance of Sterility
Distribution
CO
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-18
Company
Wheat Ridge, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 81 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PReye LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PReye LLC have FDA actions?
This is the only FDA action we have on record for PReye LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0621-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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