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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Rugby Laboratories Antiseptic Ointment Recalled for Incorrect Ingredients

Agency Publication Date: October 17, 2024
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Summary

Zhejiang Jingwei Pharmaceutical Co., Ltd. is recalling 295,164 tubes of Rugby Laboratories First Aid Antiseptic Ointment (Povidone Iodine USP 10%) because the inactive ingredients are incorrectly labeled. While the packaging lists mineral oil and petrolatum, the actual product contains polyethylene glycol 400 and polyethylene glycol 4000. Consumers should stop using the ointment and contact a healthcare professional if they have concerns.

Risk

The presence of undeclared inactive ingredients like polyethylene glycol (PEG) instead of the labeled mineral oil and petrolatum can cause unexpected skin irritation or allergic reactions in individuals sensitive to these specific polymers.

What You Should Do

  1. This recall affects Rugby Laboratories First Aid Antiseptic Ointment (Povidone Iodine USP 10%) packaged in 1 oz tubes (NDC 0536-1271-80).
  2. Check your product's packaging for lot numbers 220901, 230701, 230301, 230401, 230501, 230801, 240301, or 240501 with expiration dates between September 2024 and April 2027.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Rugby Laboratories First Aid Antiseptic Ointment, Povidone Iodine USP 10% (1 oz)
Variants: 10% Strength, Ointment, 1 oz (28.4 g) tube
Lot Numbers:
220901 (Exp. 09/30/2024)
230701 (Exp. 07/31/2026)
230301 (Exp. 03/31/2026)
230401 (Exp. 04/30/2026)
230501 (Exp. 05/31/2026)
230801 (Exp. 08/31/2026)
240301 (Exp. 03/31/2027)
240501 (Exp. 04/30/2027)
NDC:
0536-1271-80

Inactive ingredients incorrectly labeled as mineral oil and petrolatum; product actually contains polyethylene glycol 400 and 4000.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95422
Status: Active
Manufacturer: Zhejiang Jingwei Pharmaceutical Co., Ltd.
Sold By: Wholesalers; Rugby Laboratories
Manufactured In: China
Units Affected: 295,164 tubes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.