First Aid Antiseptic Ointment recall
FDA recall D-0013-2025 · initiated Sep 11, 2024
Zhejiang Jingwei Pharmaceutical Co., Ltd. recalled First Aid Antiseptic Ointment in Sep 2024 — an FDA Class II recall (D-0013-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was 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.
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 295,164 tubes
Details
- 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
- Recalling company
- Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed to one wholesaler in OH for Nationwide distribution.
- Initiated
- Sep 11, 2024
- FDA report date
- Oct 23, 2024
Frequently asked
- Was First Aid Antiseptic Ointment recalled?
- Zhejiang Jingwei Pharmaceutical Co., Ltd. recalled First Aid Antiseptic Ointment in Sep 2024 — an FDA Class II recall (D-0013-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was First Aid Antiseptic Ointment recalled?
- Per the FDA enforcement record, the reason for recall D-0013-2025 was: 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.
- Is a recalled First Aid Antiseptic Ointment dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of First Aid Antiseptic Ointment are affected?
- Distributed: Distributed to one wholesaler in OH for Nationwide distribution.. The recall covers these lots — 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0013-2025.