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CLASS II · ModerateFDA

Huons Co., Ltd. recalls Carboxymethylcellulose Sodium

📅 Oct 2, 2026 · 📍 Nationwide
Recalling company
Huons Co., Ltd.
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, 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.
Reason
Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 2, 2026
Reported
Nov 4, 2026
Distribution
Nationwide within U.S.
Status
Ongoing
Quantity
6,633,570 tubes
Lot / codes
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.
Company location
Jecheon
Recall type
Voluntary: Firm initiated
Recall number
D-0080-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0080-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.