CLASS II ONGOING Drug recall · Reported 23 Oct 2024 · FDA Enforcement Report
First Aid Antiseptic Ointment, Povidone Iodine recalled
Zhejiang Jingwei Pharmaceutical is recalling First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, distributed nationwide in the US. The recall was initiated on 11 Sep 2024 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-0013-2025
- FDA event ID
- 95422
- Recalling firm
- Zhejiang Jingwei Pharmaceutical, Quzhou
- Brand
- First Aid Antiseptic
- Manufacturer
- Rugby Laboratories
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2024
- FDA classified
- 17 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Creams, Ointments & Gels
Timeline
| 11 Sep 2024 | Recall initiated by company | |
| 17 Oct 2024 | Classified by FDA | +36 days |
| 23 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Distributed to one wholesaler in OH for Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot, expiry: Lot 220901, Exp. 09/30/2024; Lot 230701, Exp. 07/31/2026; Lot 230301, Exp. 03/31/2026; Lot 230401, Exp. 04/30/2026; Lot 230501, Exp. 05/31/2026; Lot 230801, Exp. 08/31/2026; Lot 240301, Exp. 03/31/2027; Lot 240501, Exp. 04/30/2027.
Where was it sold?
Distributed to one wholesaler in OH for Nationwide distribution.
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.
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 |