Safety Report: MAC DADDY DIETARY SUPPLEMENTS - recalled due to undeclared Sildenafil & Tadalafil, USA

United States

ABC SALES 1 INC is voluntarily recalling MAC DADDY RED Capsules, Lot 1230004, Exp 03/30/2024 and MAC DADDY PURPLE Capsules, Lot 1230005, Exp 03/30/2024 to the consumer level. ABC Sales 1 Inc was informed by Amazon that laboratory analysis found MAC DADDY RED capsules to be tainted with sildenafil and tadalafil and MAC DADDY PURPLE capsules to be tainted with tadalafil. The products were distributed via the internet and fulfilled by Amazon at www.amazon.com nationwide in the USA.

Sildenafil and tadalafil are ingredients in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of sildenafil and/or tadalafil in MAC DADDY capsules makes these products unapproved drugs for which the safety and efficacy have not been established and therefore, subject to recall.

Consumers with underlying medical issues who take MAC DADDY capsules, 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, ABC SALES 1 INC has not received any reports of adverse events related to this recall.

These products are marketed as dietary supplements for male sexual enhancement and are packaged in 10-count blisters packaged in a carton. The affected MAC DADDY RED packages include lot 1230004, Exp 03/30/2024, ASIN: B07TLDZLY2, UPC 742137605191 and MAC DADDY PURPLE packages include lot 1230005, Exp 03/30/2024, ASIN: B08Z63Z4QK, UPC 742137605764. The product can be identified by the labels attached. 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.

Consumers that have MAC DADDY RED or PURPLE capsules which are being recalled should stop using.

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

Company name: ABC SALES 1 INC
Brand name: MAC DADDY
Product recalled: MAC DADDY RED and PURPLE DIETARY SUPPLEMENTS
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: February 08, 2022

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abc-sales-1-inc-issues-voluntary-nationwide-recall-mac-daddy-red-and-mac-daddy-purple-capsules-due

Source: FDA