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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

H & H Remedies, LLC: Union Salve, Liniment, and Ointment Recalled for Manufacturing Violations

Agency Publication Date: November 9, 2020
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Summary

H & H Remedies, LLC is recalling approximately 1,556 units of Union (black) salve, White Liniment, and Vapor Ointment due to Current Good Manufacturing Practice (CGMP) deviations. These manufacturing violations mean the company cannot guarantee the quality, purity, or safety of these topical drug products. Consumers should stop using these products and contact their healthcare provider if they have experienced any issues related to their use.

Risk

Failure to follow manufacturing quality standards can result in products that are contaminated or contain incorrect levels of ingredients, which may lead to skin irritation, infections, or ineffective treatment.

What You Should Do

  1. Check your product packaging for the following identifying details: Union (black) salve (1/8 oz to 32 oz jars) with lot numbers H20-01S through H20-12S.
  2. Identify if you have White Liniment (1 oz to 6 oz bottles) with lot numbers H20-01W through H20-84W.
  3. Identify if you have Vapor Ointment (1/8 oz to 8 oz jars) with lot numbers H20-01V through H20-10V.
  4. Stop using the affected products immediately to avoid potential health risks.
  5. Contact your healthcare provider or pharmacist for guidance regarding any health concerns or if you have been using these products for medical conditions.
  6. Return any unused product to the place of purchase for a refund and contact H & H Remedies, LLC for further instructions.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Union (black) salve (1/8 oz, 2 oz, 4 oz, 8 oz, 16 oz, 32 oz)
Model:
D-0071-2021
Lot Numbers:
H20-01S
H20-02S
H20-03S
H20-04S
H20-05S
H20-06S
H20-07S
H20-08S
H20-09S
H20-10S
H20-11S
H20-12S
Product: White Liniment (1 oz, 4 oz, 6 oz)
Model:
D-0072-2021
Lot Numbers:
H20-01W thru H20-84W
Product: Vapor Ointment (1/8 oz, 2 oz, 4 oz, 8 oz)
Model:
D-0073-2021
Lot Numbers:
H20-01V thru H20-10V

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86712
Status: Resolved
Manufacturer: H & H Remedies, LLC
Sold By: H & H Remedies, LLC
Manufactured In: United States
Units Affected: 3 products (939 jars; 365 bottles; 252 jars)
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 · 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.