Why it was recalled
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Product description
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Lot numbers, UPCs & expiration codes
Lot # DK1027, Exp. 08/01/2023
Where it was sold
Product was distributed nationwide in the USA via Amazon Marketplace
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0638-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 8, 2022
- FDA report date
- Feb 23, 2022
- Quantity
- 500 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Celebrate Today
Original FDA data
Every field from FDA enforcement report D-0638-2022, exactly as published.
Show all FDA fields
- City
- Brentwood
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89563
- Address
- 143 Front Ave
- Code information
- Lot # DK1027, Exp. 08/01/2023
- Postal code
- 11717-5113
- Report date
- Feb 23, 2022
- Product type
- Drugs
- Recall number
- D-0638-2022
- Classification
- Class I
- Recalling firm
- Celebrate Today
- Product quantity
- 500 cartons
- Termination date
- Mar 29, 2022
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
- Distribution pattern
- Product was distributed nationwide in the USA via Amazon Marketplace
- Recall initiation date
- Feb 8, 2022
- Initial firm notification
- Press Release
- Center classification date
- Feb 28, 2022