First Aid Antiseptic Ointment — Class II drug recall D-0013-2025
Ongoing recall by Zhejiang Jingwei Pharmaceutical Co., Ltd., reported 2024-10-23, distributed nationwide. Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as
| Recall number | D-0013-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zhejiang Jingwei Pharmaceutical Co., Ltd., Quzhou, China |
| Recall initiated | 2024-09-11 |
| Classified | 2024-10-17 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 295,164 tubes |
| Reason classes | undeclared allergen, labeling |
| NDC | 00536-1271, 00536-1271-80 |
| Lot numbers | 220901, 230301, 230401, 230501, 230701, 230801, 240301, 240501 |
| Expiration dates | 2024-09-30, 2026-03-31, 2026-04-30, 2026-05-31, 2026-07-31, 2026-08-31, 2027-03-31, 2027-04-30 |
Product
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
Reason for recall
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
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-0013-2025. 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.