Carboxymethylcellulose Sodium Solution/ Drops
FDA Recall NDC 50268-068
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Carboxymethylcellulose Sodium (NDC 50268-068). 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
32,876 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
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 103, exp 4/26/25; Lot 104, exp 5/03/25; Lot 108, exp 6/29/25; Lot 109, exp 7/18/25; Lot 110, exp 8/17/25; Lot 111, exp 8/22/25; Lot 112, exp 8/27/25; Lot 113, exp 9/18/25; Lot 125, exp 10/23/25; Lot 130, exp 11/09/25; Lot 131, exp 11/14/25; Lot 132, exp 11/27/25; Lot 133, exp 11/30/25; Lot 134, exp 12/05/25; Lot 135, exp 12/11/25; Lot 136, exp 12/14/25; Lot 137, exp 1/02/26; Lot 139, exp 1/15/26; Lot 140, exp 1/19/26; Lot 141, exp 1/25/26; Lot 151, exp 3/18/26; Lot 152, exp 3/21/26; Lot 153, exp 3/25/26; Lot 154, exp 3/28/26; Lot 155, exp 4/01/26; Lot 156, exp 4/08/26; Lot 157, exp 4/11/26; Lot 160, exp 4/26/26; Lot 180, exp 8/08/26; Lot 181, exp 8/12/26; Lot 182, exp 8/18/26; Lot 183, exp 8/21/26; Lot 184, exp 8/26/26; Lot 185, exp 9/04/26; Lot 186, exp 9/09/26; Lot 187, exp 9/16/26; Lot 188, exp 9/18/26; Lot 189, exp 9/21/26; Lot 190, exp 9/25/26; Lot 191, exp 9/28/26; Lot 192, exp 10/02/26; Lot 208, exp 12/11/26; Lot 209, exp 12/16/26; Lot 212, exp 1/15/27; Lot 213, exp 1/21/27; Lot 214, exp 1/24/27; Lot 215, exp 2/02/27; Lot 216, exp 2/04/27; Lot 224, exp 3/27/27.
Affected Packages Involved in this Recall
50268-068-15Product
50268-068-02Product
Class III Ongoing
LABELING: LABEL MIX-UP
Dec 18, 2024
Jan 08, 2025
16,677 cartons
Recall Profile & Regulatory Data
Event ID
96032
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
AvKARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
Batch or Lot Expiration Information
Lot# : 0160, Exp. Date April 26 2026
Affected Packages Involved in this Recall
50268-068-15Product
50268-068-02Product
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.
