# FDA recall D-0013-2025

> **Zhejiang Jingwei Pharmaceutical Co., Ltd.** · Class II · drug recall initiated 2024-09-11.

## 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

## 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.

## Distribution

Distributed to one wholesaler in OH for Nationwide distribution.

## Key facts

- **Recall number:** D-0013-2025
- **Recalling firm:** Zhejiang Jingwei Pharmaceutical Co., Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-09-11
- **Report date:** 2024-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Quzhou, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2025

## Citation

> AI Analytics. FDA recall D-0013-2025. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/D-0013-2025. Source: US FDA. Licensed CC0.

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