# FDA recall D-0389-2026

> **Radnostix** · Class II · drug recall initiated 2026-01-26.

## 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.

## Reason for recall

Presence of Particulate Matter: Due to production issues

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0389-2026
- **Recalling firm:** Radnostix
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-01-26
- **Report date:** 2026-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Idaho Falls, ID, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2026

## Citation

> AI Analytics. FDA recall D-0389-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0389-2026. Source: US FDA. Licensed CC0.

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