Class IIOngoing

First Aid Antiseptic Ointment recall

FDA recall D-0013-2025 · initiated Sep 11, 2024

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.

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

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0013-2025 ↗

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