Recall Ledger

Carboxymethylcellulose Sodium recall (Huons Co., Ltd.)

DrugClass IIOngoing

Summary: Huons Co., Ltd. is recalling 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: Carboxyme. Reason: Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers.

What is being recalled

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.

Why

Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Nationwide within U.S.

How to tell if yours is 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.

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0080-2027
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedOctober 2, 2026
ReportedNovember 4, 2026
CompanyHuons Co., Ltd.
Company locationJecheon, Korea (the Republic of)
Initiated byVoluntary: Firm initiated
Quantity6,633,570 tubes

More recalls from Huons Co., Ltd. · all drug recalls · recalls from October 2026

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