May 2026 FDA Recall Drug by Preye Llc
D-0621-2026 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Preye Llc on May 18, 2026 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in CO and the recall is currently ongoing.

Recall Number: D-0621-2026

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-18-2026
Reported
07-01-2026
Quantity
approximate 50 to 60 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99032
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
PReye LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CO
Product Description About Product Description
Full technical description of the product.
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO

Batch or Lot Expiration Information

Lot# All lots within expiry