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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 565
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.
Part of a larger recall action
This product is one of 2 recalled by ABC Sales 1 Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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