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 recordRecall numberRecalling firmFDA tierReported
Systane, 10gD-0491-2026Alcon Research LLCClass II2026-05-06
GenTeal Tears, 10gD-0492-2026Alcon Research LLCClass II2026-05-06
iVIZIA, 0.5%D-0500-2026Thea Pharma, Inc.Class II2026-05-06
Similasan, 0.5%D-0501-2026Thea Pharma, Inc.Class II2026-05-06
Phenylephrine Hydrochloride Injectable Solution, 40mgD-0502-2026Wells Pharma OF Houston LLCClass II2026-05-06
fentaNYL Citrate Injectable Solution, 1000 mcg/100 mLD-0503-2026Wells Pharma OF Houston LLCClass II2026-05-06
fentaNYL Citrate injectable Solution in 0.9% Sodium ChlorideD-0504-2026Wells Pharma OF Houston LLCClass II2026-05-06
fentaNYL Citrate Injectable Solution, 1250 mcg/25mLD-0505-2026Wells Pharma OF Houston LLCClass II2026-05-06

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 recordRecall numberRecalling firmStrength / formReported
fentaNYL Citrate Injectable Solution in 0.9% Sodium ChlorideD-0506-2026Wells Pharma OF Houston LLC0.9% · Solution2026-05-06
Ketamine Hydrochloride Injectable Solution, 50mg/mlD-0507-2026Wells Pharma OF Houston LLC50mg/ml · Solution2026-05-06
fentaNYL Citrate Injectable Solution in 0.9% Sodium ChlorideD-0508-2026Wells Pharma OF Houston LLC0.9% · Solution2026-05-06
Alendronate Sodium Oral Solution, 70 mg/75 mLD-0526-2026Hikma Pharmaceuticals Usa Inc70 mg/75 mL · Oral Solution2026-05-06
Furosemide Tablets, 80 mgD-0486-2026Leading Pharma, LLC80 mg · Tablets2026-04-29
FRESHKOTE LUBRICANT EYEDROPS, 10mLD-0489-2026Harrow Eye LLC10mL2026-04-29
Omega-3-Acid, 1 gramD-0493-2026The Harvard Drug Group LLC1 gram · Capsules2026-04-29
DEXTROSE INJECTION USP, 70%D-0496-2026B Braun Medical Inc70% · Injection2026-04-29

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.