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 record | Recall number | Recalling firm | FDA tier | Reported |
|---|---|---|---|---|
| MAJOR, 0.2 mg | D-0609-2026 | The Harvard Drug Group LLC | Class II | 2026-07-01 |
| Fenofibrate Capsules, 200 mg | D-0611-2026 | Ajanta Pharma Usa Inc | Class II | 2026-07-01 |
| Corlanor (ivabradine) tablets, 5 mg | D-0612-2026 | Amgen, Inc. | Class II | 2026-07-01 |
| Sensipar (cinacalcet) Tablets, 30mg | D-0613-2026 | Amgen, Inc. | Class II | 2026-07-01 |
| Sensipar (cinacalcet) Tablets, 60mg | D-0614-2026 | Amgen, Inc. | Class II | 2026-07-01 |
| Corlanor (ivabradine) tablets, 7.5mg | D-0615-2026 | Amgen, Inc. | Class II | 2026-07-01 |
| Sensipar (cinacalcet) Tablets, 90mg | D-0616-2026 | Amgen, Inc. | Class II | 2026-07-01 |
| DULOXETINE D/R, 30 mg | D-0617-2026 | Direct RX | Class II | 2026-07-01 |
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 record | Recall number | Recalling firm | Strength / form | Reported |
|---|---|---|---|---|
| Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, 1295 mL | D-0618-2026 | Central Admixture Pharmacy Services, Inc. | 1295 mL · Injection | 2026-07-01 |
| BD ChloraPrep Clear, 2% | D-0622-2026 | Carefusion 213, LLC | 2% · Solution | 2026-07-01 |
| BD ChloraPrep FREPP Clear, 2% | D-0623-2026 | Carefusion 213, LLC | 2% · Solution | 2026-07-01 |
| Lacosamide Tablets, 100mg | D-0626-2026 | Annora Pharma Private Ltd | 100mg · Tablets | 2026-07-01 |
| Povi-One, 10% | D-0627-2026 | Elevate Oral Care | 10% | 2026-07-01 |
| Perampanel CIII Tablets, 6mg | D-0628-2026 | Sun Pharmaceutical Industries Inc | 6mg · Tablets | 2026-07-01 |
| Alyacen 7/7/7, 0.5mg/0.035mg | D-0588-2026 | Glenmark Pharmaceuticals Inc., Usa | 0.5mg/0.035mg · Tablets | 2026-06-24 |
| VistaPharm, 25 Grams | D-0589-2026 | Pai Holdings LLC | 25 Grams | 2026-06-24 |
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.