Dietary Supplements

The FSAI announced the recall of Aptonia sports food products by Decathlon due to the presence of the unauthorized pesticide ethylene oxide. Ethylene oxide is a pesticide that is not permitted for use in foods sold in the EU but is approved for use by other countries... See More outside the EU.

The recalled products are:
- Aptonia Vitamins and Minerals 30 tablets Orange flavour
- Aptonia salts caps 100 capsules
- Aptonia Electrolytes tablets Ecosize lemon flavour 2x20 tablets
- Aptonia Electrolytes tablets rasperry flavour 2x20 tablets
- Aptonia Electrolytes tablets lemon flavour 2x20 tablets

Although the consumption of the contaminated product does not pose an acute risk to health, there is an increased risk if there is continued consumption of contaminated food over a long period of time. Therefore, exposure to this substance needs to be minimized.

In case you are experiencing food poisoning symptoms, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance.

For more recall details check on FSAI website: fsai.ie

Source: FSAI See Less

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Company name: Je Dois L’avoir Boutique
Brand name: 365 Skinny
Product recalled: High Intensity Pills and Emergency Boutique
Reason of the recall: Product contains sibutramine
FDA Recall date: August 02, 2021
Recall details: Hanford, California, Je Dois L’avoir Boutique is voluntarily recalling all of the 365 Skinny... See More High Intensity Pills and or 365 Skinny Emergency Boutique, 30 day capsules supply to the retail/consumer level. The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique have been found to contain Sibutramine which is a controlled substance by the DEA and poses significant health risks to consumers both products are from the same manufacturer 365 Skinny is the strongest form and the 365 Skinny Emergency is for people with high blood pressure, diabetes but not limited to other chronic illnesses.

Risk Statement: The 365 Skinny High Intensity Pills and 365 Skinny Emergency Boutique potentially can cause serious health risks such as seizures, tachycardia, palpitations, heart attacks and allergic reactions. Risks associated with this product are more likely with people who have high blood pressure, thyroid disease, men or woman over 65 or children under 16 years old. Je Dois L’avoir Boutique has not received any reports of adverse events related to this recall.

The product is used together with diet and exercise to assist with weight loss and is packaged in bottles of 30 capsules 600mg per capsule. All lots and expiration dates of any of these products are being recalled. Je Dois L’avoir is recalling ALL 365 Skinny High Intensity Pills and 365 Emergency Boutique that it has sold to the public as seen below. Je Dois L’avoir is notifying its distributors and customers by email and is arranging for return/replacement etc. of all recalled products. Consumers that have 365 High Intensity Skinny or 365 Skinny Emergency Boutique which is being recalled should stop using/return to place of purchase/discard/contact Je Dois L’avoir Boutique Immediately.

Check the full recall details on fda.gov

Source: FDA See Less

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Company name: HIS
Brand name: HIS
Product recalled: Dietary Supplement for Weight Loss
Reason of the recall: Undeclared Sibutramine
FDA Recall date: July 22, 2021
Recall details: Palisades Park, NJ, HIS is voluntarily recalling all lots and all presentations of Miss Slim (10 count & 30 count... See More capsules) to the consumer level. HIS decided to recall Miss Slim after it was contacted by the FDA regarding the presence of sibutramine in the product.

Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues. The presence of sibutramine in Miss Slim renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. To date, HIS has not received any reports of adverse events related to this recall.

The product is marketed as a dietary supplement and is packaged 10 count UPC (742137605030) and 30 count UPC (609728434472) capsules. The product sold online at missslimusa.com.

Risk Statement: Products containing sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

HIS is notifying its customers by website missslimusa.com and is arranging for return of all recalled products. Consumers that have Miss Slim which is being recalled should stop using it. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on fda.gov

Source: FDA See Less

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Company name: Alpha Male Plus
Brand name: Alpha Male Plus
Product recalled: Alpha Male Plus Male Enhancer fruit chew
Reason of the recall: Undeclared Tadalafil
FDA Recall date: July 19, 2021
Recall details: Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha... See More Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Consumers with underlying medical conditions who take Alpha Male Plus Male Enhancer with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Alpha Male Plus has not received any reports of adverse events related to this recall.

The tainted Alpha Male Plus Male Enhancer product was manufactured by Dr Manuel Mascarenas M.D. in Tucson, Arizona located at 5190 E Farness Dr Ste 104, 85712. Dr Mascarenas is the originator and manufacturer of these products for the global market. Alpha Male Plus was selected to act as the US distributor and distribute these products for the US market.

The tadalafil ingredient was never disclosed or made known to its US distributor and was only discovered through FDA laboratory analysis. Dr Manuel Mascarenas is solely responsible for the creation, formulation and proliferation of this product. Through the use of concealment, dishonest means and an unknowing 3rd party Dr Mascarenas was able to begin distributing this mislabeled and potentially harmful product to the US market.

Alpha Male Plus was marketed as a dietary supplement for male sexual enhancement and is packaged in 1strip per foil pouch within a cardboard box, UPC [8 60003 03770 6] [8 60003 74512 0].

The affected Alpha Male Plus Male Enhancer includes all lots. The product was distributed nationwide in the USA via internet directly to consumers via their website.

Company is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using or return to place of purchase/discard/contact their doctor, etc.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA See Less

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Company name: Miracle8989
Brand name: PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 capsules
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: May 19, 2021
Recall details: Irving, Texas, Miracle8989 is voluntarily recalling all... See More lots PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000, capsules to the consumer level. FDA analysis has found the products to contain undeclared sildenafil and tadalafil.  Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.  The presence of Sildenafil and Tadalafil in PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Consumers with underlying medical issues who take PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 with undeclared Sildenafil and Tadalafil may experience serious health risks.  For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.  Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

To date, Ebay Seller Annie Cho has not received any reports of adverse events related to this recall.

The tainted PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 products are marketed as dietary supplements for male sexual enhancement and is packaged in 1 count blister cards. The affected PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 include all lot numbers and all expiration dates. The product can be identified by the product name and the UPC codes below distributed nationwide via internet.

Product Name UPC codes
PremierZen Gold 7000 728175421832
PremierZen Platinum 8000 728175421832
MaxxZEN Platinum 12000 718122040728

Miracle8989 is notifying its distributors and customers by sending eBay messages and is arranging for return of all recalled products. Consumers that have PremierZen Gold 7000, PremierZen Platinum 8000, and MaxxZEN Platinum 12000 which is being recalled should stop using.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax.

Check the full recall details on fda.gov

Source: FDA See Less

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Company name: Dash Xclusive
Brand name: Imperia Elita
Product recalled: Vitaccino Coffee weight loss and anxiety dietary supplement
Reason of the recall: Undeclared Sibutramine and Fluoxetine
FDA Recall date: May 11, 2021
Recall details: Glendale, California, Dash Xclusive is voluntarily recalling all lots of Imperia Elita Vitaccino... See More Coffee to the consumer level. FDA analysis has found the product to contain undeclared sibutramine and fluoxetine. Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.

Fluoxetine is an FDA approved drug indicated for the treatment of various depressive disorders, obsessive compulsive disorder, bulimia and panic disorders. This drug product carries a box warning for suicidal thoughts and behaviors and it needs to be monitored closely by a prescriber. The presence of sibutramine and fluoxetine in Imperia Elita Vitaccino coffee renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. Dash Xclusive has not received any reports of adverse events related to this recall.

Risk Statement: Products containing undeclared sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Products containing undeclared fluoxetine could cause suicidal thinking and behavior, an accumulation of high levels of serotonin in the body or neuroleptic malignant syndrome (NMS)-like reactions which is a life-threatening neurological disorder; elevated mood state that can cause higher than normal energy levels, restlessness, decreased need for sleep; abnormal bleeding, and low sodium levels.

The product is marketed  as a dietary supplement for weight loss and is packaged in a black rectangular box and contains fifteen sachets. The affected Imperia Elita Vitaccino coffee lots include all lots. Product was distributed Nationwide in the USA via internet and by ebay at www.ebay.com. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Dash Xclusive is notifying its customers by e-messages on the eBay platform and is arranging for return of all recalled products. Consumers that have Imperia Elita Vitaccino Coffee which is being recalled should stop using/return to Dash Xclusive, 610 S. Verdugo Road, Apt 31, Glendale, California 91205. Consumers with questions regarding this recall can contact Dash Xclusive by e-mail at dashxclusive11@gmail.com on Mondays to Thursdays from 11am to 4pm Pacific Time zone. 

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax. Complete and submit the report Online. Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA See Less

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Company name: Mountain Rose Herbs
Brand name: Mountain Rose Herbs
Product recalled: Organic Kudzu Root Herbal Supplement
Reason of the recall: Potential to be contaminated with Salmonella
FDA Recall date: March 18, 2020
Recall details: Mountain Rose Herbs (MRH) of Eugene, Oregon is recalling all sizes of... See More its Organic Kudzu Root Herbal Supplement from Lot #24247-X and #24247 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. The product comes in a clear plastic or poly-woven bag, net weight ranges from 4 oz. to 50 lbs., marked with lot #24247-X and #24247. The lot number is located on the principal display panel on the lower left of the label (see linked label examples). The recalled Organic Kudzu Root Herbal Supplement was distributed to customers who ordered from mountainroseherbs.com, purchased at the company’s retail shop in Eugene, Oregon, or placed mail orders by phone or fax between the dates of 6/17/2019 to 3/2/2020. It is possible MRH customers also resold the Kudzu Root to their own clientele. Mountain Rose Herbs also distributed product directly to customers in AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, British of Columbia, Nova Scotia, Ontario, and Quebec of Canada.No illnesses have been reported to date. We are initiating this recall as a precautionary measure. The potential for contamination was noted after testing by the company revealed the presence of Salmonella in a portion of its ingredients in inventory. Production of the product has been suspended while we continue our investigation. We conduct this recall with the knowledge of the U.S. Food and Drug Administration. Consumers who have purchased the affected Kudzu Root are urged not to consume and should return product to the place of purchase for a full refund.
Check the full recall details on fda.gov
Source: FDA See Less

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