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
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 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03
Affected NDCs
67618-0153-01
67618-0153-03
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
- Avrio Health L.P
- NDC code
- 67618-153-01
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0828-2021 · 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.
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Class II · Moderate risk
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Class II · Moderate risk
BD PurPrep
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Other wrong potency / content recalls from 2021
All wrong potency / content recalls
Class II · Moderate risk
Pioglitazone Tablets USP
Superpotent and Failed Tablet/Capsule Specifications
Class II · Moderate risk
Penicillin V Potassium for Oral Solution
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Class III · Low risk
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000…
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Class III · Low risk
CariFree sample boxes
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
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