Optase Solution/ Drops
FDA Recall NDC 72972-002

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Optase (NDC 72972-002). A significant event, classified as Class II, was initiated on Apr 20, 2026 by Scope Health Inc. The reported reason for this action was: "Lack of Assurance of Sterility"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0499-2026ONGOING

April 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0499-2026
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility
Initiated
Apr 20, 2026
Reported
May 06, 2026
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
98802
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SCOPE HEALTH
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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.
Batch or Lot Expiration Information
Lot# : 8T98, 9T31, 9T32, Exp. Date: 30/04/26; 2V13, 2V14, 2V15, Exp. Date 30/06/26; 3V35, Exp. Date 31/08/26;3V36, 3V37, Exp. Date 30/09/26; 5V45, 5V46, 9V12, Exp. Date 31/03/27; 1X57, 1X70, 1X84, Exp. Date 31/05/27.
Affected Packages Involved in this Recall
72972-002-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.