FDA Drugs recall ·
First Aid Antiseptic Ointment, Povidone Iodine USP 10%… recall
- Recall number
- D-0013-2025
- Date
- (initiated September 11, 2024)
- Company / brand
- Zhejiang Jingwei Pharmaceutical Co., Ltd.
Wengjia Road, Changshan Industrial Park No.19, Quzhou, China - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 295,164 tubes
- Hazard tags
- Undeclared allergen
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Distributed to one wholesaler in OH for Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0013-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.