Sodium Chloride Hypertonicity Ophthalmic Solution, 5% Solution/ Drops
FDA Recall NDC 69618-077

Latest: Class II · Status: Ongoing · Initiated Aug 20, 2026 · 1 enforcement report

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Sodium Chloride Hypertonicity Ophthalmic Solution, 5% (NDC 69618-077). A significant event, classified as Class II, was initiated on Aug 20, 2026 by Reliable 1 Laboritories Llc. 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-0856-2026ONGOING

August 2026 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0856-2026
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility
Initiated
Aug 20, 2026
Reported
Sep 30, 2026
Quantity
11083 bottles

Recall Profile & Regulatory Data

Event ID
99712
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Sterling Pharmaceutical Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.
Batch or Lot Expiration Information
Lot# 3192, Exp Date 01/312027; 3293, 3336 Exp Date 06/30/2027
Affected Packages Involved in this Recall
69618-077-55Sodium Chloride Hypertonicity Ophthalmic Solution, 5%

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.