Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

Is Iohexol recalled?

Yes — there is an active recall. 2 ongoing FDA recalls mention Iohexol (7 total). Check the affected lots below.

Most common reason: Sterility / contamination (3 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Iohexol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Iohexol recalls in 2026

2 initiated in 2026, 7 in total — newest first
Class I · High risk

Iohexol (300 mg Iodine/mL)

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

Terminated Labeling / mix-up BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy D-0086-2023
Class II · Moderate risk

Iohexol

Lack of Assurance of Sterility

Terminated Sterility / contamination Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical NDC 71283-1413-5 D-0979-2020
Class II · Moderate risk

Omnipaque (iohexol)

Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.

Terminated Packaging defect GE Healthcare Inc. Life Sciences NDC 0407-1411-20 D-0319-2019
Class II · Moderate risk

Iopamidol 41% Injectable 198 Ml 99 Ml 50 Ml 600 Ml 72 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1549-2012
Class II · Moderate risk

Iohexol 200mg Iodine/Ml Injectable 120 Ml 300 Ml 50 Ml 600 Ml 72 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1548-2012