Why it was recalled
Presence of Particulate Matter: Due to production issues
Product description
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
Lot numbers, UPCs & expiration codes
Batch I012626R-01, Exp 02/09/2026
Where it was sold
Nationwide in the USA and Puerto Rico
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-0389-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 26, 2026
- FDA report date
- Mar 11, 2026
- Quantity
- 16 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Radnostix
Original FDA data
Every field from FDA enforcement report D-0389-2026, exactly as published.
Show all FDA fields
- City
- Idaho Falls
- State
- ID
- Status
- Ongoing
- Country
- United States
- Event ID
- 98470
- Address
- 4137 Commerce Cir
- Code information
- Batch I012626R-01, Exp 02/09/2026
- Postal code
- 83401-1205
- Report date
- Mar 11, 2026
- Product type
- Drugs
- Recall number
- D-0389-2026
- Classification
- Class II
- Recalling firm
- Radnostix
- Product quantity
- 16 units
- Reason for recall
- Presence of Particulate Matter: Due to production issues
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jan 26, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 13, 2026