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Class II Recall — Risk of Temporary or Reversible Adverse Health Consequences
Verified · FDAClass II — Possible RiskMedications

SODIUM IODIDE I-131 Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, ND Recall 2026

SODIUM IODIDE I-131Issued January 26, 2026

SODIUM IODIDE I-131 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 — recalled per FDA on 1/26/2026. Reason: Presence of Particulate Matter: Due to production issues.

Issuing agency
FDA
Issued
Jan 26, 2026
Brand
SODIUM IODIDE I-131
Distribution
1 states

What to do right now

  1. 1

    Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. 2

    Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. 3

    Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

Verified source

U.S. Food and Drug Administration

Summary of the official FDA notice issued January 26, 2026. Last synced Apr 16, 2026. View on fda.gov

What's recalled

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.

Why it was recalled

Presence of Particulate Matter: Due to production issues

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Batch I012626R-01
Exp 02/09/2026
Where was it sold
1 state

Nationwide in the USA and Puerto Rico

nationwide
View official FDA notice

View all questions for this recall →

More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the SODIUM IODIDE I-131 recall still active?

Yes, this recall is currently active as of January 26, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Batch I012626R-01, Exp 02/09/2026. Check the label on your product.

What should I do if I have the recalled SODIUM IODIDE I-131?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.