Class III · Low risk
Is Iodine recalled?
Yes — there is an active recall. 10 ongoing FDA recalls mention Iodine (45 total). Check the affected lots below.
Most common reason: Wrong potency / content (15 of these recalls)
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 in 2026
6 initiated in 2026, 45 in total — newest first
Class I · High risk
Optiray Imaging Bulk Package-350
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Class II · Moderate risk
BD PurPrep
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Class II · Moderate risk
Povi-One
sub potency
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Class III · Low risk
Readyprep Pvp
Subpotent drug
Class II · Moderate risk
Iodo Blanco Iodides
Defective Container: broken or leaking bottles.
Class II · Moderate risk
First Aid Antiseptic Ointment
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Class II · Moderate risk
Lugol's (Strong Iodine Solution USP)
CGMP Deviations: Products not manufactured under current good manufacturing practices.
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
Class II · Moderate risk
Betadine 5%
cGMP deviations: Temperature abuse
Class II · Moderate risk
Betadine (povidone-iodine)
Lack of Assurance of Sterility
Class II · Moderate risk
Betadine Solution Swabstick Povidone-Iodine Solution USP
Subpotent Drug
Class II · Moderate risk
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidine Iodine Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Prep Pad Large
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Prep Pad MEDIUM
SubPotent: Out of Specification
Class II · Moderate risk
Betadine (Povidone-Iodine)
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Class II · Moderate risk
Povidone Iodine
Lack of sterility assurance.
Class II · Moderate risk
Optiray 320
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Class II · Moderate risk
PVP Scrub Solution
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
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