Premium OrgaZen & Ginseng Power Supplement Recall [US]

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US/Silver Spring: NS NY Distributor Inc. recalls all current batch/lots of Premium OrgaZen 7000 and Ginseng Power 5000 Dietary Supplements from the American marketplace due to reported undeclared Sildenafil and Tadalafil, two FDA approved drugs for the treatment of Male Erectile Dysfunction (“ED”), Benign Prostatic Hyperplasia (“BPH”) and certain other medical conditions and in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors with consequential risks of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/tLLD30rEos8

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ns-ny-distributor-inc-issues-voluntary-nationwide-recall-premium-orgazen-7000-and-ginseng-power-5000

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

Nuri Shogun-X 7000, 69MODE & Thumbs Up 7 Supplements

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US/Silver Spring: Nuri Trading, a Newton, New Jersey, establishment, recalls all current batch/lots of Shogun-X 7000 Supplement Capsules, 69MODE Blue 69 Supplement Capsules, Thumbs Up 7 (Black) 25K Supplement Capsules and Thumbs Up 7 (White) 11K Supplement Capsules from the American marketplace due to reported undeclared Sildenafil, Tadalafil and Vardenafil, three (3) FDA approved drugs for the treatment of Male Erectile Dysfunction (“ED”), Benign Prostatic Hyperplasia (“BPH”) and certain other medical conditions and in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors with consequential risks of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/4jiJ30rDJ1l

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nuri-trading-llc-issues-voluntary-nationwide-recall-shogun-x-7000-thumbs-7-black-25k-thumbs-7-white

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

Ummzy Krazy Night, Shogun-X & Thumbs Up Recall [US]

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US/Silver Spring: Ummzy LLC, a Palisades Park, New Jersey establishment, recalls all current batch/lots of Krazy Night Dietary Supplement Capsules, Shogun-X 15000 mg Dietary Supplement Capsules and Thumbs Up 7 Red 70K Dietary Supplement Capsules from the American marketplace due to reported undeclared Sildenafil, Tadalafil and Vardenafil, three (3) FDA approved drugs for the treatment of Male Erectile Dysfunction (“ED”), Benign Prostatic Hyperplasia (“BPH”) and certain other medical conditions and in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors with consequential risks of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/TkLw30rDCMy

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ummzy-llc-issues-voluntary-nationwide-recall-thumbs-7-red-70k-shogun-x-15000mg-and-krazy-night-due

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

Bit & Bet Thumbs Up 7 Blue 69K Supplement Recall [US]

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US/Silver Spring: Bit & Bet LLC, a Manassas, Virginia establishment, recalls all batch/lots of Bit & Bet Thumbs Up 7 Blue 69K Supplement Capsules from the American marketplace due to reported undeclared Sildenafil and Tadalafil, two FDA approved drugs for the treatment of Male Erectile Dysfunction (“ED”), Benign Prostatic Hyperplasia (“BPH”) and certain other medical conditions and in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors with consequential risks of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/GcCM30rDtk4

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bit-bet-llc-issues-voluntary-nationwide-recall-thumbs-7-blue-69k-due-presence-undeclared-sildenafil

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

Antoto-K Thumbs Up 7 Red 70K Supplement Recall [US]

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US/Silver Spring: Antoto-K, a Manassas, Virginia establishment, recalls all batch/lots of Thumbs Up 7 Red 70K Capsules from the American marketplace due to suspected undeclared Sildenafil and Tadalafil, two FDA approved drugs for the treatment of Male Erectile Dysfunction (“ED”), Benign Prostatic Hyperplasia (“BPH”) and certain other medical conditions and in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors with consequential risks of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/S1MB30rDgNO

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/antoto-k-issues-voluntary-nationwide-recall-thumbs-7-red-70k-due-presence-undeclared-sildenafil-and

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

Adam’s Secret Extra Strength Capsule Recall [US]

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US/Silver Spring: Adamssecret.co, a Fairview, New Jersey establishment, recalls all batch/lots of Adam’s Secret branded Extra Strength 1500 and 3000 Capsules  from the American marketplace due to suspected undeclared Sildenafil and Tadalafil, two FDA approved drugs for the treatment of Male Erectile Dysfunction (“ED”), Benign Prostatic Hyperplasia (“BPH”) and certain other medical conditions and in a class of drugs called Phosphodiesterase (“PDE-5”) Inhibitors with consequential risks of dangerous low blood pressure, injury and possible life-changing complications, all serious health and safety hazards.

FDA: http://ht.ly/cUYB30ryp01

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamssecretco-issues-voluntary-nationwide-recall-adams-secret-extra-strength-1500-and-3000-capsules

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

Red-E Male Enhancement Supplement Recall [US]

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US/Silver Spring: The Protein Shoppe, LLC, a Pharr, Texas establishment, recalls certain batch/lots of Red-E Male Enhancement Tablet products from the American marketplace 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/hLfX30r80lE

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/protein-shoppe-llc-issues-voluntary-nationwide-recall-red-e-male-enhancement-tablet-due-presence

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

Up2 Dietary & Bow and Arrow Supplement Recall [US]

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US/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:

Silver Bullet Male Enhancement Supplement Recall [US]

US/Silver Spring: Spring: 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:

Up2 All Natural Libido Dietary Supplement Recall [US]

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US/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:

Stiff Boy branded Beast Supplement Recall [US]

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US/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:

Leopard Miracle Honey Dietary Supplement Recall [US]

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US/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:

Rhino 5k Dietary Supplement Recall [US]

US/Silver Spring: 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:

MyNicNaxs Nutritional Supplement Recall [US]

US/Silver Spring: 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):

Marmex Blue Pearl Nutritional Supplement Recall [US]

US/Silver Spring: Marmex Corporation, an Orange, California establishment, recalls all current batch/lots of Blue Pearl All Natural Male Enhancement Supplements due to undeclared Sildenafil, an active ingredient in an FDA-approved prescription drug used to treat male sexual dysfunction, making this product a new drug for which safety and efficacy has not been established, all serious health and safety hazards. FDA: http://ht.ly/sr0230hew4f

Direct link: https://www.fda.gov/Safety/Recalls/ucm588969.htm

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