FDA-Drug2026-10-26Class IICHEMICAL
Huons carboxymethylcellulose sodium lubricant eye drops recalled for plastic contamination
What this means
Huons carboxymethylcellulose sodium lubricant eye drops in single-use containers were found to contain a plastic-related compound (polyethylene leachable) at levels above acceptable limits. The contamination was detected during quality testing. Affected lots have expiration dates ranging from March 2027 to October 2028.
- Check your eye drops container for the brand name and lot number on the packaging.
- If you have an affected lot, stop using the product and contact your pharmacy or healthcare provider.
- Do not use eye drops from the affected lots, even if the container appears normal.
- Consult your eye care provider about safe alternatives for lubricating eye drops.
The agency's original wording
Hazard
Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related leachable compound above the Analytical Evaluation Threshold (AET)
Intended for
All ages
Illnesses reported
None reported
Sold states
Nationwide within U.S.
Affected count
6,633,570 tubes
Manufactured in
137 Bio Valley-Ro, Jecheon, Korea (the Republic of)
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0080-2027Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.