The Recall Desk
SevereFDA (Drugs)·D-0562-2022·Announced 2022-02-23

MAC DADDY RED Capsules Recalled for Undeclared Drug Ingredients

MAC DADDY RED Capsules are being recalled because they contain undeclared tadalafil and/or sildenafil without FDA approval. The product was distributed nationwide via Amazon Marketplace.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I. According to the severity rubric, FDA Class I recalls are never scored below 4, and this case qualifies as Severe because it involves an unapproved drug marketed with undeclared pharmaceutical ingredients that pose a risk of harm.

Plain-English summary

ABC Sales 1 Inc is recalling MAC DADDY RED Capsules packaged in 10-count blisters per carton (ASIN B07TLDZLY2, UPC 742137 605191, Lot #1230004, Exp. date 03/30/2024). The product contains undeclared tadalafil and/or sildenafil, active ingredients found in FDA-approved products for male sexual enhancement. Because these ingredients are present without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), the product is an unapproved drug.

Approximately 565 cartons were distributed nationwide in the USA via Amazon Marketplace. Consumers who have purchased this product should stop use and contact the manufacturer or a healthcare provider with questions.

The recalled product

Product
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
Manufacturer
ABC Sales 1 Inc
Hazard
  • unapproved-drug
  • undeclared-tadalafil
  • undeclared-sildenafil

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 1230004
  • Exp. date 03/30/2024

Distribution

Distributed nationwide across the United States.