Goldenseal Root Powder Recall: Contamination Could Cause Infant Death

Maison Terre has issued a Goldenseal Root Powder recall due to microbial contamination.  There are many uses for Goldenseal Root Powder, including among women and infants.  It can be used to help heal the umbilical cord stump after birth.  So far, there is at least one report of an infant death after the product was applied for this use.

Consumers who use this herbal product should be aware of the recall and the signs of illness related to the contamination.  The U.S. Food and Drug Administration (FDA) says,

“The use of contaminated product in otherwise healthy patients can result in infections necessitating antimicrobial and potentially surgical treatment.  In individuals with weak immune systems and infants, the use of the product can result in death.”

Goldenseal Root Powder Recall Information

 According to a Company Announcement from the FDA, Goldenseal Root Powder recall affects all lots of the product distributed by Maison Terre.  An FDA analysis of product samples revealed that the products are contaminated with various microorganisms.  The FDA lists the following microorganisms that may lead to illness:

  • Enterobacter cloacae
  • Cronobacter sakazakii
  • Cronobacter dublinensis

The products subject to recall include Goldenseal Root Powder packaged in a clear plastic bag.  It was purchased from Starwest Botanicals and was repackaged for consumer purchase.  The one ounce packages were likely purchased between January 2015 and August 2020.  The majority of the products subject to recall were purchased through Amazon, but the products were distributed nationwide. 

The FDA urges consumers to dispose of any unused product subject to this Goldenseal Root Powder recall.  Consumers may be able to return the product and receive a refund.  Maison Terre is offering consumers a pre-paid shipping label. 

Consumers who have questions about the recall can contact Masion Terre by calling 501-888-9438. 

What is Goldenseal Root Powder Used For?

Goldenseal is an herb. The root is harvested and dried to use medicinally.  It contains the chemical berberine, which can fight bacteria and fungi.  Berberine is also useful to reduce inflammation, improve irregular heartbeat, lower blood pressure and lower bad cholesterol.  It is useful for adults, children and even infants for a variety of conditions.  In infants, it is primarily used to treat skin problems, colds and jaundice. 

There are many possible uses for goldenseal, but there is little evidence to support just how effective the root really is.  Commonly, consumers use goldenseal for:

  • Treating colds, stuffy nose and respiratory infections.
  • Calming digestive disorders like stomach pain, gastritis, ulcers, constipation and diarrhea.
  • Treating urinary tract infections (UTIs).
  • Managing symptoms of whooping cough and pneumonia.
  • Treating bleeding after childbirth.
  • Treating jaundice.
  • Relieves menstrual problems and symptoms.
  • Treating skin rashes, wounds, infections, ulcers, acne, dandruff, eczema, ringworm and cold sores. 
  • Relieves sore gums.
  • Relieves eye irritations like conjunctivitis and pink eye.
  • Treating ringing of the ears, earache and deafness.

Because there is little evidence to support the efficacy of goldenseal, it is important to talk to your healthcare provider before introducing goldenseal into your medicine cabinet. 

Microorganism Contamination Leading to Goldenseal Root Powder Recall

Per the FDA notice, the Maison Terre Goldenseal Root Powder recall is due to tests showing the presence of potentially dangerous microorganisms.  Below, we discuss each of the microorganisms and why they may be dangerous to consumers. 

Enterobacter cloacae

Enterobacter cloacae is a nosocomial pathogen that is responsible for various infections.  This pathogen can cause infections in even healthy individuals.  This opportunistic pathogen contains an endotoxin that easily causes complications and sepsis.  Enterobacter cloacae can cause individual infections and community-spread infections.  It can quickly become resistant to antibiotics. 

Symptoms of bacteremia caused by Enterobacter cloacae include:

  • Increase in heart rate
  • Increase in respiratory rate
  • Fever
  • Hypotension
  • Septic shock

Symptoms of lower respiratory tract infections caused by Enterobacter cloacae include:

  • High fever
  • Hypothermia
  • Tachycardia (high heart rate)
  • Hypoxemia (low blood oxygen level)
  • Cyanosis (skin discoloration)

Cronobacter sakazakii and dublinensis

The Centers for Disease Control and Prevention (CDC) considers Cronobacter as a multi-species complex.  These gram-negative bacteria exist in the natural environment and can survive in fairly harsh conditions.  Cronobacter can live in dry foods, herbal teas, starches and infant formula. 

Illnesses related to Cronobacter are relatively rare, but when they do occur, they can be dangerous.  The CDC notes that these infections are especially dangerous for the elderly and immunocompromised.  Illnesses due to Cronobacter can affect people of all ages, however.  The CDC notes the following:

All Age Groups: Cronobacter may cause infections such as:

  • Urinary tract infections (UTIs)
  • Wound infections
  • Bloodstream infections
  • Respiratory tract infections

Infants: Infants under 12 months old may experience the following infections from Cronobacter:

Among infants, the mortality rate for Cronobacter meningitis is as high as 40 percent. 

Reporting Illness from Goldenseal Root Powder

If you or someone in your household has used Goldenseal Root Powder and then developed an illness due to one of these microorganisms, it is important to report your experience.  The FDA urges consumers to use their MedWatch Adverse Event Reporting program to report adverse events related to the Goldenseal Root Powder recall. 

You may also find it helpful to contact a birth injury lawyer to discuss your situation.  You have certain rights as a consumer. If you or your child suffer harm due to a defective or contaminated product, you deserve to know your options.  If you have questions or concerns about a defective infant product, contact Birth Injury Guide.  Call us at 1-877-415-6603. 

Sam Uribe

Written By Sam Uribe

Sam Uribe is a researcher and writer. She lends her expertise to the team at Birth Injury Guide to provide up-to-date and relevant content that clients can count on.