Lubricant Eye Drops Solution
FDA Recall NDC 50268-126
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 Lubricant Eye Drops Solution (NDC 50268-126). A significant event, classified as Class II, was initiated on Apr 23, 2025 by Avpak. The reported reason for this action was: "cGMP deviations and 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.
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
April 2025 Class II Recall: cGMP deviations and lack of assurance of sterility.
Recall Number
Class II Ongoing
cGMP deviations and lack of assurance of sterility.
Apr 23, 2025
May 14, 2025
13,104 cases (24 cartons per case)
Recall Profile & Regulatory Data
Event ID
96741
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
BRS Analytical Services, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26; Lot 206, exp 12/02/26; Lot 219, exp 2/24/27; Lot 221, exp 3/02/27; Lot 222, exp 3/05/27.
Affected Packages Involved in this Recall
50268-126-15Product
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.
