Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported October 23, 2024
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
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Zhejiang Jingwei Pharmaceutical Co., Ltd. recalled First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil… - a moderate-severity action.
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil… was recalled by Zhejiang Jingwei Pharmaceutical Co., Ltd. in October 23, 2024. Reason: Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed a…. Check the official notice for the remedy. Verify recall #D-0013-2025 with the FDA Drug before acting.
The recall
Zhejiang Jingwei Pharmaceutical Co., Ltd. issued this moderate-severity FDA Drug recall-Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed a….
- Moderate
- severity level
- Class II
- classification
- October 23, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0013-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0013-2025) was formally reported on October 23, 2024, with the manufacturer initiating the action on September 11, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Zhejiang Jingwei Pharmaceutical Co., Ltd. is listed as the recalling firm, operating out of Quzhou. Federal records list the affected scope as 295,164 tubes.
The documented reason for this recall is: 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 , po… Distribution data in the federal record shows the product reached: Distributed to one wholesaler in OH for Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Dietary Supplements recalls over time
Where this recall sits in its category - 2,002 dietary supplements recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
295,164 tubes
Related Recalls
6
0 from same agency
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
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 Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0013-2025 |
| Date reported | October 23, 2024 |
| Date initiated | September 11, 2024 |
| Recalling firm | Zhejiang Jingwei Pharmaceutical Co., Ltd. |
| Firm location | Quzhou |
| Affected scope | 295,164 tubes |
| Distribution | Distributed to one wholesaler in OH for Nationwide distribution. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0013-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zhejiang Jingwei Pharmaceutical Co., Ltd.. Units affected: 295,164 tubes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 23, 2024. Severity: Moderate. Recall number: D-0013-2025.
Where was the recalled product distributed? ▼
Distribution: Distributed to one wholesaler in OH for Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0013-2025) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with Blue Bull Extreme Male Enhancement Supplement, total of 15 … →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 23, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.