Why it was recalled
Lack of Assurance of Sterility
Product description
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
USA Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0531-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 2, 2026
- FDA report date
- Apr 22, 2026
- Quantity
- 7,120,750 ampules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Huons Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-0531-2026, exactly as published.
Show all FDA fields
- City
- Jecheon
- Status
- Ongoing
- Country
- Korea (the Republic of)
- Event ID
- 98724
- Address
- 100 Bio-Valley-Ro
- Code information
- All lots within expiry
- Report date
- Apr 22, 2026
- Product type
- Drugs
- Recall number
- D-0531-2026
- Classification
- Class II
- Recalling firm
- Huons Co., Ltd.
- Product quantity
- 7,120,750 ampules
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- Apr 2, 2026
- Center classification date
- May 15, 2026