Quality & complianceOfficial

FDA classifies Huons carboxymethylcellulose sodium recall as Class II over polyethylene-related oligomers

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The recall, numbered D-0080-2027, is ongoing and covers distribution nationwide within the US after a product failed impurities and degradation specifications.

The US Food and Drug Administration has listed a Class II drug recall of carboxymethylcellulose sodium made by Huons Co., Ltd. in its enforcement report dated 4 November 2026. The recall carries the number D-0080-2027.

The stated reason is a failure to meet the impurities and degradation specification. The entry points to the detection of polyethylene (PE)-related oligomers as the underlying finding.

The enforcement report gives the recall's status as ongoing. Distribution is described as nationwide within the US.

The page text supplied contains only search-tool navigation and help instructions. It does not give the product strength, lot numbers, quantities, the date of the initial recall or the corrective action required, so none of these can be reported here.

For context, FDA assigns Class II to recalls where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams using or sourcing carboxymethylcellulose sodium from Huons should check the full FDA enforcement entry for affected products and lot details.
  • The cited cause, PE-related oligomers, is a reminder to review impurity and degradation controls for products that may interact with polymer-based packaging or components.
  • Distributors and pharmacies in the US should confirm whether any affected stock is held, as the recall is ongoing and covers nationwide distribution.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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