Back to Alerts List

New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients

Including Super Fat Burner Capsules, Maxi Gold Capsules, and Esmeralda Softgels

[Posted 03/26/2014]

AUDIENCE: Consumer

ISSUE: New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established.

BACKGROUND: These products are used as weight loss aids and are packaged in 30 capsule bottles. New Life Nutritional Center distributed these products to customers residing in NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through their website at www.newlifenutritional.com.

RECOMMENDATION: New Life Nutritional Center is notifying its customers by letter. Customers are advised to immediately discontinue use of these products and should return the products immediately to New Life Nutritional Center 714 West 181st Street NY, NY 10033 for a refund.

[03/26/2014 - Press Release - New Life Nutritional Center]
[03/26/2014 - Photos - FDA]

Related Safety Alerts

E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults [Posted 4/3/2019]
Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products [Posted 7/19/2018]
Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination [Posted 6/22/2018]
X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination [Posted 5/29/2018]
95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol [Posted 5/23/2018]
Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder [Posted 5/23/2018]
Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls [Posted 5/21/2018]
Rhino 69 Extreme 50000 by AMA Wholesale: Recall - Presence of Tadalafil [Posted 4/18/2018]
Euphoric Capsules by Epic Products: Recall - Undeclared Sildenafil and Tadalafil [Posted 4/18/2018]
Maeng Da Red Powder and Capsules by Club 13: Recall - Possible Contamination With Salmonella [Posted 4/10/2018]

New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients

Related Safety Alerts

Registry Sponsors