Optase Dry Eye Intense Drops (Glycerin 0.2%) recall — Scope Health (Class II)
Scope Health is recorded by the U.S. Food and Drug Administration (FDA) as recalling Optase Dry Eye Intense Drops (Glycerin 0.2%) — a Class II recall, initiated 2026-04-20 and posted to the FDA enforcement report on 2026-05-06, under recall number D-0499-2026. 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 drops, the strength given is 0.2% and the package is described as 0.33 fl oz. 1 National Drug Code number is printed in the record: 72972-002-01. Distribution is recorded as “Nationwide within the United States” — Nationwide (US), with the recalling firm on record in NY, United States. It is the only recall number the FDA has filed under event ID 98802. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.
Regulatory snapshot
| Recall number | D-0499-2026 |
|---|---|
| FDA event ID | 98802 |
| Classification | Class II (intermediate regulatory tier) |
| Status | Ongoing |
| Recalling firm | Scope Health |
| Recall initiated | 2026-04-20 |
| Reported by FDA | 2026-05-06 |
| Report lag | 16 days from initiation to report |
| Distribution | Nationwide within the United States — Nationwide (US) |
| Firm location on record | NY, United States |
| Product description (source) | Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01. |
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
4 identifying values matched by exact pattern in the 30-word product description above; each is a literal substring of it.
| Product named | Optase Dry Eye Intense Drops (Glycerin 0.2%) |
|---|---|
| Form | Drops |
| Strength | 0.2% |
| Package | 0.33 fl oz |
| NDC | 72972-002-01 |
Reported in the same month (2026-05)
48 enforcement reports carry a report date in 2026-05; these 8 are the Class II ones nearest this record.
| Recall record | Recall number | Recalling firm | FDA tier | Reported |
|---|---|---|---|---|
| Systane, 10g | D-0491-2026 | Alcon Research LLC | Class II | 2026-05-06 |
| GenTeal Tears, 10g | D-0492-2026 | Alcon Research LLC | Class II | 2026-05-06 |
| iVIZIA, 0.5% | D-0500-2026 | Thea Pharma, Inc. | Class II | 2026-05-06 |
| Similasan, 0.5% | D-0501-2026 | Thea Pharma, Inc. | Class II | 2026-05-06 |
| Phenylephrine Hydrochloride Injectable Solution, 40mg | D-0502-2026 | Wells Pharma OF Houston LLC | Class II | 2026-05-06 |
| fentaNYL Citrate Injectable Solution, 1000 mcg/100 mL | D-0503-2026 | Wells Pharma OF Houston LLC | Class II | 2026-05-06 |
| fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride | D-0504-2026 | Wells Pharma OF Houston LLC | Class II | 2026-05-06 |
| fentaNYL Citrate Injectable Solution, 1250 mcg/25mL | D-0505-2026 | Wells Pharma OF Houston LLC | Class II | 2026-05-06 |
Nearest Class II recalls by date
213 of 250 indexed records share the Class II tier; the 8 nearest to 2026-05-06 by report date are listed here.
| Recall record | Recall number | Recalling firm | Strength / form | Reported |
|---|---|---|---|---|
| fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride | D-0506-2026 | Wells Pharma OF Houston LLC | 0.9% · Solution | 2026-05-06 |
| Ketamine Hydrochloride Injectable Solution, 50mg/ml | D-0507-2026 | Wells Pharma OF Houston LLC | 50mg/ml · Solution | 2026-05-06 |
| fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride | D-0508-2026 | Wells Pharma OF Houston LLC | 0.9% · Solution | 2026-05-06 |
| Alendronate Sodium Oral Solution, 70 mg/75 mL | D-0526-2026 | Hikma Pharmaceuticals Usa Inc | 70 mg/75 mL · Oral Solution | 2026-05-06 |
| Furosemide Tablets, 80 mg | D-0486-2026 | Leading Pharma, LLC | 80 mg · Tablets | 2026-04-29 |
| FRESHKOTE LUBRICANT EYEDROPS, 10mL | D-0489-2026 | Harrow Eye LLC | 10mL | 2026-04-29 |
| Omega-3-Acid, 1 gram | D-0493-2026 | The Harvard Drug Group LLC | 1 gram · Capsules | 2026-04-29 |
| DEXTROSE INJECTION USP, 70% | D-0496-2026 | B Braun Medical Inc | 70% · Injection | 2026-04-29 |
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. Match a package against 72972-002-01 at the FDA source to confirm it is covered.
Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Scope Health (1 indexed records) aggregates this firm across datasets.
Coverage and limits of this record
This page reflects the openFDA enforcement report for D-0499-2026 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-0499-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-05-06
- Ingested
- 2026-08-22
- Record hash
a23cdf774c54429a
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.