FDA Recall D-0389-2026

Radnostix · Idaho Falls, ID

Class II Ongoing 108 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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 / code: Batch I012626R-01, Exp 02/09/2026

Quantity: 16 units

Reason for recall

Presence of Particulate Matter: Due to production issues

Recall record

Recall number: D-0389-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA and Puerto Rico
Recall initiated: 2026-01-26
Classified by FDA Center: 2026-03-13
FDA published: 2026-03-11
Recalling firm: Radnostix
Firm location: Idaho Falls, ID

Drug identification

Brand name(s): SODIUM IODIDE I-131
Generic name(s): SODIUM IODIDE I-131
Manufacturer(s): Radnostix, Inc.
NDC(s): 69208-000
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls