Class III · Low risk
Betadine Solution Swabstick Povidone-Iodine Solution USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Affected NDC
67618-0153-01
Compare with the code on your package — it is the most precise check available.
Drug: Iodine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Betadine Solution Swabsticks Povidone-Iodine NDC 67618-0153 |
10 mg/mL | Solution Topical |
Atlantis Consumer Healthcare, Inc. | OTC |
- Recalling firm
- Purdue Pharma, LP
- NDC code
- 67618-153-01
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0070-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Iodine recalls
See all
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
Other wrong potency / content recalls from 2017
All wrong potency / content recalls
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity Specifications
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class II · Moderate risk
Viokace (pancrelipase)
Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.