RED MAMMOTH 400 mg Capsules Recalled for Undeclared Active Pharmaceutical Ingredients
RED MAMMOTH capsules, 400 mg (Lot # DK1027, Exp. 08/01/2023) are being recalled because they contain undeclared sildenafil and tadalafil, making them an unapproved drug marketed without FDA authorization.
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: This recall is classified as FDA Class I. The source text states the product was "marketed without an Approved NDA/ANDA," which is the agency's own Class I designation. Per the severity rubric, FDA Class I recalls must receive a score of at least 4.
Plain-English summary
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton (ASIN B00KA8FBNI, barcode X001ANE0I5), are being recalled by Celebrate Today, the manufacturer.
The product was found to contain undeclared sildenafil and tadalafil, active ingredients found in FDA-approved products for male sexual enhancement. Because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is classified as an unapproved drug.
The affected product (Lot # DK1027, Exp. 08/01/2023) was distributed nationwide in the USA via Amazon Marketplace. Consumers who have purchased this product should stop use immediately and consult a healthcare provider if they have any health concerns.
The recalled product
- Product
- RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
- Manufacturer
- Celebrate Today
- Category
- Drug — Unapproved Drug
- Affected units
- 500
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 # DK1027
- Exp. 08/01/2023
Distribution
Distributed nationwide across the United States.
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