Huons Co., Ltd.: Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-use Containers, 0.02 Fl Oz (0
Recall Summary Huons Co., Ltd. is recalling Carboxymethylcellulose Sodium 0.5% Lubricant Eye Drops (30 single-use containers, 0.5 mL each, NDC 51407-945-30) distributed nationwide across all U.S. states and Washington, D.C. The product failed quality testing because it contains a chemical compound from polyethylene packaging above acceptable levels. This is classified as a Class II recall, meaning the product could cause adverse health effects.
- Recalling firm
- 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 leachable compound above the Analytical Evaluation Threshold (AET)
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-10-02
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within U.S.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/473b51fa-3f9e-492c-bc04-215b2ebdfd26