FDA Recall D-0401-2026

Radnostix · Idaho Falls, ID

Class III Ongoing 84 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35

Lot / code: Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027

Quantity: 2,699 blister cartons

Reason for recall

Failed Tablet/Capsule Specifications

Recall record

Recall number: D-0401-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US, including Puerto Rico
Recall initiated: 2026-02-19
Classified by FDA Center: 2026-03-20
FDA published: 2026-04-01
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 III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

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

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