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.
Product description
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
Lot numbers, UPCs & expiration codes
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 it was sold
Distributed to one wholesaler in OH for Nationwide distribution.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0013-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 11, 2024
- FDA report date
- Oct 23, 2024
- Quantity
- 295,164 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zhejiang Jingwei Pharmaceutical Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-0013-2025, exactly as published.
Show all FDA fields
- City
- Quzhou
- Status
- Ongoing
- Country
- China
- Event ID
- 95422
- Address
- Wengjia Road, Changshan Industrial Park No.19
- Code information
- 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.
- Report date
- Oct 23, 2024
- Product type
- Drugs
- Recall number
- D-0013-2025
- Classification
- Class II
- Recalling firm
- Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Product quantity
- 295,164 tubes
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed to one wholesaler in OH for Nationwide distribution.
- Recall initiation date
- Sep 11, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 17, 2024