FDA recall, , Moderate risk
Huons Carboxymethylcellulose Sodium Lubricant Eye Drops
Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops may contain more impurities than allowed.
Summary by Recall Canary from the FDA notice
What happened
Huons Co., Ltd., of Jecheon, Korea (the Republic of), voluntarily recalled Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-Use Containers, 0.02 FL OZ (0.5 mL) each, because the product failed impurities and degradation specifications. The FDA reported detection of a polyethylene (PE)-related leachable compound above the Analytical Evaluation Threshold (AET). The recall began October 2, 2026, and was added to the FDA's Enforcement Report on October 26, 2026.
The product was distributed nationwide within the U.S. and was manufactured by Huons Co., Ltd., and marketed by GSMS Incorporated, Camarillo, CA 93012, USA. The recall involved 6,633,570 tubes.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops
- NDC
- 51407-945-30
- Lot code
- 2EQH501
- 2EQH502
- 2EQH503
- 2EQH504
- 2EQH505
- 2EQH506
- 2EQH507
- 2EQH508
- 2EQH509
- 2EQH510
- 2EQH511
- 2EQH512
- 2EQH513
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Nationwide within U.S.
- Recalled by
- Huons Co., Ltd.Jecheon, Korea (the Republic of)
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100011
- Recall number
- D-0080-2027
- Quantity recalled
- 6,633,570 tubes
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
All recalls from Huons Co., Ltd.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Huons began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
