Betadine Solution Swabstick Povidone-Iodine Solution USP — Class II drug recall D-0070-2018
Terminated recall by Purdue Pharma, LP, reported 2017-11-15, distributed nationwide. Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact
| Recall number | D-0070-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Purdue Pharma, LP, Stamford, CT, United States |
| Recall initiated | 2017-10-05 |
| Classified | 2017-11-03 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2020-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 3,997 swabsticks |
| Reason classes | potency |
| NDC | 67618-0153, 67618-0153-01, 67618-0153-03 |
| Lot numbers | 62823, 64304, 64711, 65915 |
| Expiration dates | 2018-12-31, 2019-05-31, 2019-08-31, 2019-12-31 |
Product
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0070-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.