CLASS II Drug recall · Reported 15 Nov 2017 · FDA Enforcement Report
Betadine Solution Swabstick Povidone-Iodine Solution recalled
Purdue Pharma is recalling Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products, distributed nationwide in the US. The recall was initiated on 5 Oct 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0070-2018
- FDA event ID
- 78229
- Recalling firm
- Purdue Pharma, Stamford, CT
- Brand
- Betadine
- Manufacturer
- Atlantis Consumer Healthcare, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Oct 2017
- FDA classified
- 3 Nov 2017
- Reported
- 15 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Oct 2017 | Recall initiated by company | |
| 3 Nov 2017 | Classified by FDA | +29 days |
| 15 Nov 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it 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.
Which lots are affected?
Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Purdue Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV recalled | Purdue Pharma | Potency & Assay | 8 states |
| Drug | CLASS III | Intermezzo (zolpidem tartrate) recalled by Purdue Pharma | Purdue Pharma | Potency & Assay | Nationwide |
Other Povidone-iodine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | BD PurPrep, (Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | Povi-One, 10% Povidone-Iodine Oral Antiseptic recalledPovi-one | Elevate Oral Care | Potency & Assay | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD PurPrep, Povidone-iodine 8.3% w/w recalled by CareFusion 213Purprep | CareFusion 213 | Sterility | Nationwide |