Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Iodine recalled?

Yes — there is an active recall. 10 ongoing FDA recalls mention Iodine (45 total). Check the affected lots below.

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

Iodine recalls on record

none so far in 2026; 45 on record, newest first
Class II · Moderate risk

Nose to Toes Skin Antisepsis

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

Terminated Cross-contamination Sage Products Inc D-0411-2018
Class II · Moderate risk

Povidone Iodine

Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.

Terminated Labeling / mix-up Degasa Sa De Cv NDC 68345-350-09 D-1129-2017
Class II · Moderate risk

MD-Gastroview

Labeling: incorrect or missing lot number and/or expiration date

Terminated Labeling / mix-up Mallinckrodt, Inc. NDC 0019-4816-04 D-1132-2015
Class II · Moderate risk

Gastrografin

Presence of foreign substance: One lot of the product may contain black foreign particles

Terminated Particulate / foreign matter Bracco Diagnostics Inc NDC 0270-0445-40 D-885-2013
Class II · Moderate risk

Iodine 20 mg Injection

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Ongoing Sterility / contamination Lowlite Investments, Inc. D/B/A Olympia Pharmacy D-743-2013
Class II · Moderate risk

FREPP/SEPP Kit containing 1 FREPP

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Terminated Labeling / mix-up CareFusion 213, LLC NDC 54365-202-99 D-229-2013
Class II · Moderate risk

Donor Prep Kit containing 1 FREPP

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Terminated Labeling / mix-up CareFusion 213, LLC NDC 54365-201-99 D-228-2013
Class II · Moderate risk

Blood Culture Prep Kit II containing 1 FREPP

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Terminated Labeling / mix-up CareFusion 213, LLC NDC 54365-200-99 D-227-2013
Class II · Moderate risk

SEPP 10% Povidone Iodine Solution USP

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Terminated Labeling / mix-up CareFusion 213, LLC NDC 54365-145-01 D-226-2013
Class II · Moderate risk

SEPP 2% Iodine Tincture USP

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Terminated Labeling / mix-up CareFusion 213, LLC NDC 54365-161-01 D-225-2013
Class II · Moderate risk

Povidone-Iodine/Lidocaine/Tetracaine 4.6%/4%/0.5% Ophthalmic 30 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-1605-2012
Class II · Moderate risk

Povidone-Iodine Ophthalmic 5% Solution 10 Ml 125 Ml 15 Ml 40 Ml 50 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-1604-2012
Class II · Moderate risk

Phenyleph/Diclof/Tropic/Proparac/Povidone Iodine Sol…

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-1598-2012
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