PharmacovigilanceOfficial

Game Changer Products recalls all lots of 10 Day Forecast capsules over hidden sildenafil

🇺🇸 FDA MedWatch · Thu 12 Nov 2026

FDA analysis found the male sexual enhancement product, sold online and via eBay since at least October 2021, contains undeclared sildenafil and acetaminophen; no adverse events have been reported.

Game Changer Products LLC, based in Tampa, Florida, is voluntarily recalling all lots of its 10 Day Forecast capsules to the consumer level across the US. The company announced the recall on 12 November 2026, the same day FDA published it on its MedWatch recalls page.

FDA analysis found the product, marketed as a male sexual enhancement supplement, to be tainted with sildenafil and acetaminophen. Neither ingredient was declared. Sildenafil is the active ingredient in an FDA-approved prescription medicine for erectile dysfunction, while acetaminophen is used to relieve pain and reduce fever. Because of this, the notice says the capsules are unapproved new drugs whose safety and efficacy have not been established, and they cannot be sold as dietary supplements.

The risk statement highlights two hazards. Undeclared sildenafil may interact with nitrates, such as nitroglycerin, causing a significant and potentially life-threatening fall in blood pressure. Men taking nitrates for cardiac conditions are described as most at risk. Hidden acetaminophen could lead to unintentional double dosing in people already taking it, with possible liver damage ranging from mild problems to liver failure and death, as well as anaphylaxis and serious skin reactions. The company says it has received no adverse event reports linked to the recall.

The capsules come in cards of one or two blue capsules, with UPC 191645852717 and a black background with white lettering. Lot numbers and expiry dates are printed on the back of each card, and all are included. Sales ran nationwide, including Puerto Rico, Guam and the Northern Mariana Islands, from at least October 2021 to 17 October 2026, through the company's website, eBay and one retail store in Minnesota. The company is notifying customers by email and through eBay messaging, and the store by letter. Consumers are told to stop using the product and discard it safely, and to contact a health professional if they have problems. Adverse reactions can be reported to FDA's MedWatch programme.

What it means for your team

  • Pharmacovigilance teams should note that adverse event reports involving male enhancement products may reflect undeclared sildenafil or acetaminophen, with nitrate interactions and hepatotoxicity as the key concerns.
  • The recall's long sales window, from at least October 2021 to October 2026, and its online and marketplace distribution show how tainted products can circulate for years outside conventional supply chains.
  • Quality and compliance teams monitoring online channels can treat this as another example of FDA treating products containing prescription drug ingredients as unapproved new drugs rather than dietary supplements.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

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