Recall Reason Description
Undeclared Sildenafil and/or Tadalafil
MAC DADDY RED and PURPLE DIETARY SUPPLEMENTS
FOR IMMEDIATE RELEASE – 2/8/22 – Monsey, NY, 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. 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 below. The products were distributed via the internet and fulfilled by Amazon at www.amazon.com nationwide in the USA. 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.
ABC SALES 1 INC is notifying its customers by this press announcement and sending Amazon messages to its customers and is arranging for return of all recalled products. Consumers that have MAC DADDY RED or PURPLE capsules which are being recalled should stop using.
Consumers with questions regarding this recall can contact Josh Green at 845-459-0632 Monday – Thursday 10:00 am to 4:00 pm EST. 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: www.fda.gov/medwatch/report.htm1
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 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.