Carboxymethylcellulose Sodium 0.5% Recall: Impurity Out of Spec
Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-Use Containers, 0.02 FL OZ (0.5 mL) each, Manufactured by: Huons Co., Ltd…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Carboxymethylcellulose Sodium 0.5% recalled?
Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-Use Containers, 0.02 FL OZ (0.5 mL) each, Manufactured by: Huons Co., Ltd, Jecheon-si, Chungcheongbuk-do, 27159, South Korea; Marketed by: GSMS Incorporated, Camarillo, CA 93012, USA. NDC 51407-945-30 Pouch Label: Carboxymethylcellulose Sodium, Lubricant Eye Drops, 0.5 mL, Single-Use, gsms.
Which lot codes, UPCs or models are affected?
Lot: 2EQH501, Exp. 3/12/2027; 2EQH502, 2EQH503, 2EQH504, 2EQH505, Exp. 3/16/2027; 2EQH506, 2EQH507, Exp. 5/22/2027; 2EQH508, Exp. 5/26/2027; 2EQH509, Exp. 5/27/2027; 2EQH510, 2EQH511, 2EQH512, 2EQH513, Exp. 10/13/2028.
- Agency record number
- D-0080-2027
- Product
- Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-Use Containers, 0.02 FL OZ (0.5 mL) each, Manufactured by: Huons Co., Ltd…
- Recalling firm
- Huons Co., Ltd.
- Quantity
- 6,633,570 tubes
- Distribution
- Nationwide within U.S.
- Recall started
- October 2, 2026
- Report date
- November 4, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)