FDA Drug recall D-0070-2018
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
- FDA Drug
- Class II
- terminated
- Published 2017-11-15
On 2017-11-15 the FDA classified a Class II recall of Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01 by Purdue Pharma, citing 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 iod….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0070-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-05 |
| Published | 2017-11-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Purdue Pharma |
| Distribution | US |
Product
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Reason
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.
Identifiers
| ndc | 67618-153-01 |
|---|---|
| ndc | 67618-153-03 |
| code_info | Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0070-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.