FDA Drugs recall ·
Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile… recall
- Recall number
- D-0080-2027
- Date
- (initiated October 2, 2026)
- Company / brand
- Huons Co., Ltd.
137 Bio Valley-Ro, Jecheon, Korea (the Republic of) - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6,633,570 tubes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Nationwide within U.S.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0080-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.