PReye Vitamin See Antioxidant Preservative Free Eye Drops recall — Preye LLC (Class II)

Preye LLC is recorded by the U.S. Food and Drug Administration (FDA) as recalling PReye Vitamin See Antioxidant Preservative Free Eye Drops — a Class II recall, initiated 2026-05-18 and posted to the FDA enforcement report on 2026-07-01, under recall number D-0621-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Lack of Assurance of Sterility”. From the product description, the form is eye drops. Distribution is recorded as “CO” — Limited / regional distribution, with the recalling firm on record in CO, United States. It is the only recall number the FDA has filed under event ID 99032. 44 days separate the firm's initiation date from the FDA's report date on this record. It is distributed by PReye, LLC. 213 of the indexed records carry the same Class II tier. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number D-0621-2026
FDA event ID 99032
Classification Class II (intermediate regulatory tier)
Status Ongoing
Recalling firm Preye LLC
Recall initiated 2026-05-18
Reported by FDA 2026-07-01
Report lag 44 days from initiation to report
Distribution CO — Limited / regional distribution
Firm location on record CO, United States
Product description (source) PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO

Reason reported by FDA

Lack of Assurance of Sterility

5 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

2 identifying values matched by exact pattern in the 14-word product description above; each is a literal substring of it.

Product named PReye Vitamin See Antioxidant Preservative Free Eye Drops
Form Eye Drops
Distributed by PReye, LLC

Reported in the same month (2026-07)

111 enforcement reports carry a report date in 2026-07; these 8 are the Class II ones nearest this record.

Recall recordRecall numberRecalling firmFDA tierReported
MAJOR, 0.2 mgD-0609-2026The Harvard Drug Group LLCClass II2026-07-01
Fenofibrate Capsules, 200 mgD-0611-2026Ajanta Pharma Usa IncClass II2026-07-01
Corlanor (ivabradine) tablets, 5 mgD-0612-2026Amgen, Inc.Class II2026-07-01
Sensipar (cinacalcet) Tablets, 30mgD-0613-2026Amgen, Inc.Class II2026-07-01
Sensipar (cinacalcet) Tablets, 60mgD-0614-2026Amgen, Inc.Class II2026-07-01
Corlanor (ivabradine) tablets, 7.5mgD-0615-2026Amgen, Inc.Class II2026-07-01
Sensipar (cinacalcet) Tablets, 90mgD-0616-2026Amgen, Inc.Class II2026-07-01
DULOXETINE D/R, 30 mgD-0617-2026Direct RXClass II2026-07-01

Nearest Class II recalls by date

213 of 250 indexed records share the Class II tier; the 8 nearest to 2026-07-01 by report date are listed here.

Recall recordRecall numberRecalling firmStrength / formReported
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, 1295 mLD-0618-2026Central Admixture Pharmacy Services, Inc.1295 mL · Injection2026-07-01
BD ChloraPrep Clear, 2%D-0622-2026Carefusion 213, LLC2% · Solution2026-07-01
BD ChloraPrep FREPP Clear, 2%D-0623-2026Carefusion 213, LLC2% · Solution2026-07-01
Lacosamide Tablets, 100mgD-0626-2026Annora Pharma Private Ltd100mg · Tablets2026-07-01
Povi-One, 10%D-0627-2026Elevate Oral Care10%2026-07-01
Perampanel CIII Tablets, 6mgD-0628-2026Sun Pharmaceutical Industries Inc6mg · Tablets2026-07-01
Alyacen 7/7/7, 0.5mg/0.035mgD-0588-2026Glenmark Pharmaceuticals Inc., Usa0.5mg/0.035mg · Tablets2026-06-24
VistaPharm, 25 GramsD-0589-2026Pai Holdings LLC25 Grams2026-06-24

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Preye LLC (1 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0621-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.

Source & provenance

Official source
https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0621-2026%22
Source dataset
openFDA Drug Enforcement API
Publication date
2026-07-01
Ingested
2026-08-22
Record hash
73fae508881f4b68

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.