Sundial Herbal Dietary Supplement Recall [US]

Sundial Herbal Dietary Supplement Recall [US]

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US FlagUS/Silver Spring: Sundial Herbal Products, a Bronx, New York establishment, recalls all Sundial branded Dietary and Nutritional Supplement products, marketed, sold and delivered from January 1, 2014 to the date of this notification that have labeling that contains and/or make drug claims stating the product(s) can diagnose, cure, mitigate, treat or prevent any disease or condition.

FDA: http://ht.ly/gPQa30qXznA

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sundial-herbal-products-recalling-products-attached-because-these-products-were-misbranded-products

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplements are subject to this recall:

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Active Male Dietary Supplement Recall [US]

Active Male Dietary Supplement Recall [US]

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US FlagUS/Silver Spring: Natural Remedy Store, a San Antonio, Texas establishment, recalls all current batch/lots of Active Male Dietary Supplement Capsules due to suspected undeclared Tadalafil, an existing FDA approved drug for certain medical conditions and legally available only under prescription from a licensed physician. The undeclared presence of this medication can pose a serious health and safety hazard for some people.

FDA: http://ht.ly/W7RA30qrMHX

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-remedy-store-issues-voluntary-worldwide-recall-active-male-due-presence-undeclared-tadalafil

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement products are subject to this recall:

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Up2 Dietary & Bow and Arrow Supplement Recall [US]

Up2 Dietary & Bow and Arrow Supplement Recall [US]

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US FlagUS/Silver Spring: Med Man Distribution, a Sault Sainte Marie, Ontario establishment, recalls certain batch/lots of Up2 Dietary Supplement and Bow and Arrow Dietary Supplement products due to suspected undeclared Sildenafil, an FDA approved drug for the treatment of Male Erectile Dysfunction in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors and consequential risk of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/uwGo30qkrwi

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/med-man-expands-voluntary-nationwide-recall-up2-and-bow-arrow-due-presence-undeclared-sildenafil

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement Capsules are subject to this recall:

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Silver Bullet Male Enhancement Supplement Recall [US]

US FlagUS/Silver Spring: Logo - Silver BulletSpring: Nature’s Rx, a Claremont, California establishment, recalls batch/lots of Nature’s Rx Silver Bullet Male Enhancement Capsules due to suspected undeclared Sildenafil, an FDA approved drug for the treatment of Male Erectile Dysfunction in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors and consequential risk of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/67hD30pTxfA

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natures-rx-issues-voluntary-nationwide-recall-silver-bullet-10-male-enhancement-capsules-due

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement Capsules are subject to this recall:

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Up2 All Natural Libido Dietary Supplement Recall [US]

Up2 All Natural Libido Dietary Supplement Recall [US]

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US FlagUS/Silver Spring: Med Man Distribution, a Sault Ste. Marie, Ontario establishment, recalls certain batch/lots of Up2 There Is No Other All Natural Libido for Men & Women Dietary Supplements due to suspected undeclared Sildenafil, an FDA approved drug for the treatment of Male Erectile Dysfunction in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors and consequential risk of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/8Bao30pSpI4

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/med-man-issues-voluntary-nationwide-recall-up2-due-presence-undeclared-sildenafil

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement Capsules are subject to this recall:

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Green Lumber Dietary Supplement Recall [US]

Green Lumber Dietary Supplement Recall [US]

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US FlagUS/Silver Spring: GL Holdings, a Newport Beach, California establishment, recalls numerous batch/lots of Green Lumber Dietary Supplement Capsules due to suspected undeclared Tadalafil, an existing FDA approved drug for certain medical conditions. The undeclared presence of this medication can pose a serious health and safety hazard for some people.

FDA: http://ht.ly/dBa430pLE8Y

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gl-holdings-issues-voluntary-worldwide-recall-green-lumber-products-due-presence-undeclared

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement products are subject to this recall:

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Stiff Boy branded Beast Supplement Recall [US]

Stiff Boy branded Beast Supplement Recall [US]

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US FlagUS/Silver Spring: Stiff Boy LLC, a Westchester County, New York establishment, recalls all current batch/lots of The Beast Dietary Supplement Capsules due to suspected undeclared Sildenafil, an FDA approved drug for the treatment of Male Erectile Dysfunction in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors and consequential risk of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/FyMw30oHizo

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stiff-boy-llc-issues-voluntary-nationwide-recall-beast-capsules-due-presence-undeclared-sildenafil

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement Capsules are subject to this recall:

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Leopard Miracle Honey Dietary Supplement Recall [US]

Leopard Miracle Honey Dietary Supplement Recall [US]

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US FlagUS/Silver Spring: USA LESS, a Brooklyn, New York establishment, recalls certain batch/lots of Leopard Miracle Honey Dietary Supplement ptoducts due to undeclared Sildenafil. The presence of Sildenafil in the Leopard Miracle Honey Dietary Supplement products, renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

FDA: http://ht.ly/OKBj30obFny

Direct link: https://www.fda.gov/Safety/Recalls/ucm634314.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement products are subject to this recall:

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Rhino 5k Dietary Supplement Recall [US]

US FlagUS/Silver Spring: Rhino 5k Dietary Supplement Recall [US]Happy Together, Inc. a Boynton Beach, Florida, establishment, recalls all current batch/lots of Rhino 5k Dietary Supplement Capsules due to suspected Sildenafil and Tadalafil contamination, all serious health and safety hazards.

FDA: http://ht.ly/JBPm30nfyPo

Direct link: https://www.fda.gov/Safety/Recalls/ucm629353.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplement products are subject to this recall:

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Zero Xtreme branded Nutritional Supplement Recall [US]

US FlagUS/Silver Spring: Zero Xtreme branded Nutritional Supplement Recall [US]Zero Xtreme, a Marathon, Florida establishment, recalls certain batch/lots of Zero Xtreme branded Nutritional Supplement Capsules due to suspected presence of Sibutramine, a controlled substance under FDA regulation that was marketed as an appetite suppressant but withdrawn from the US market in 2010 due to suspected increased risks of Cardiovascular Events and Stroke, all serious health and safety hazards.

FDA: http://ht.ly/InAy30mgeRW

Direct link: https://www.fda.gov/Safety/Recalls/ucm623503.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following over-the-counter (“OTC”) drugs are subject to this recall:

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MyNicNaxs Nutritional Supplement Recall [US]

US FlagUS/Silver Spring: MyNicNaxs Nutritional Supplement Recall [US]MyNicNaxs, LLC, a Deltona, Florida establishment, has recalled all lots of various Dietary Supplements due to suspected presence of Diclofenac, Phenolphthalein, Sibutramine and/or Sildenafil, all controlled substances and undeclared active pharmaceutical ingredients (“APIs”). The presence of Diclofenac, Phenolphthalein, Sibutramine and/or Sildenafil in the recalled Dietary Supplements renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Due to their ingredients, these Supplements all pose serious health and safety hazards. FDA: http://ht.ly/zYCx30kVBsI

Direct link: https://www.fda.gov/Safety/Recalls/ucm613197.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following over-the-counter (“OTC”) drugs are subject to this recall (in alphabetical order):

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Rhino 50K Supplement Recall [US]

US FlagUS/Silver Spring: Rhino 50K Supplement Recall [US]AMA Wholesale Inc., a Woodland Hills, California establishment, recalls certain batch/lots of Rhino 69 Extreme 50000 Dietary Supplement Capsules due to suspected presence of Tadalafil, a controlled substance available only under prescription, rendering this Supplement an unapproved drug due to the possibility of fatal cardiovascular events, all serious health hazards. FDA: http://ht.ly/gfKG30jyV2G

Direct link: https://www.fda.gov/Safety/Recalls/ucm604633.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Supplements are subject to this recall:

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Bella branded Diet Capsule Recall [US]

US FlagUS/Silver Spring: Bella branded Diet Capsule Recall [US]Bella all Natural, a Los Angeles, California establishment, recalls certain batch/lots of Bella branded Diet Capsules due to suspected presence of N-Desmethyl Sibutramine, an active metabolite of Sibutramine, a controlled substance under FDA regulation that was marketed as an appetite suppressant but withdrawn from the US market in 2010 due to suspected increased risks of Cardiovascular Events and Stroke, all serious health and safety hazards. FDA: http://ht.ly/lVq130iG43F

Direct link: https://www.fda.gov/Safety/Recalls/ucm598087.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following over-the-counter (“OTC”) drugs are subject to this recall:

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Man of Steel brand Supplement Recall [US]

US FlagUS/Silver Spring: Man of Steel brand Supplement Recall [US]Man of Steel recalls certain batch/lots of Man of Steel 1 and Man of Steel 2 Supplements due to suspected presence of Sildenafil, an active ingredient in FDA-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (PDE-5), rendering the Supplements unapproved Drugs due to the possibility of serious complications and fatal cardiovascular events, all serious health hazards. FDA: http://ht.ly/j6jW30e3ymH

Direct link: https://www.fda.gov/Safety/Recalls/ucm569173.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplements are subject to this recall:

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LaBri’s Atomic & Xplode Supplement Recall [US]

US FlagUS/Silver Spring: LaBri's Body Health brand Atomic and Xplode Dietary SupplementsEZ Weight Loss TX LLC recalls all current batch/lots of LaBri’s Body Health brand Atomic and Xplode Dietary Supplements due to the suspected presence of Sibutramine, an appetite suppressant that was withdrawn from the US market in October 2010 for safety reasons. Due to the suspected inclusion of Sibutramine, both of the above Supplements are classed by the US Food and Drug Administration as new drugs for which safety and efficacy have not been established and, therefore subject to recall due to serious health and safety hazards. FDA: http://ht.ly/dfZx30dU5ww

Direct link: https://www.fda.gov/Safety/Recalls/ucm568364.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Supplements are subject to this recall:

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