Aplicare Povidone-Iodine Prep Pad — Class II drug recall D-0252-2018
Terminated recall by Medline Industries Inc, reported 2018-02-07, distributed nationwide. Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
| Recall number | D-0252-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2017-09-21 |
| Classified | 2018-02-04 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2023-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, CN, HN, IL, IN, MX, MY, TR |
| Quantity | 11,750 cases |
| Reason classes | labeling, potency |
| NDC | 52380-0111-01 |
| Lot numbers | 58368, 58371, 58471, 58472, 58499, 58686, 58687, 58688, 58816, 58817, 58818, 59002, 59003, 59004, 59333, 59334, 59335, 59574, 59723, 59724, 59725, 60157, 60237, 60373, 60374, 60375, 60507, 60586, 60807, 61101, 61187, 61368, 61427, 61523, 61618, 61750, 61751, 61998, 61999, 62067 and 36 more |
| Model numbers | 58368, 66404, 66549, P-1001, P-1001-8S, P-1011, P-1011-8S |
Product
Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1
Reason for recall
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
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-0252-2018. 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.