FDA Recall D-0013-2025

Zhejiang Jingwei Pharmaceutical Co., Ltd.

Class II Ongoing 610 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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.

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.

Recall record

Recall number: D-0013-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed to one wholesaler in OH for Nationwide distribution.
Recall initiated: 2024-09-11
Classified by FDA Center: 2024-10-17
FDA published: 2024-10-23
Recalling firm: Zhejiang Jingwei Pharmaceutical Co., Ltd.

Drug identification

Brand name(s): FIRST AID ANTISEPTIC
Generic name(s): POVIDONE-IODINE
Manufacturer(s): Rugby Laboratories
NDC(s): 0536-1271
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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