CLASS I Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
RED Mammoth capsules, 400 mg recalled by Celebrate Today
Celebrate Today is recalling RED Mammoth capsules, 400 mg, distributed nationwide in the US. The recall was initiated on 8 Feb 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0638-2022
- FDA event ID
- 89563
- Recalling firm
- Celebrate Today, Brentwood, NY
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 Feb 2022
- FDA classified
- 28 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 8 Feb 2022 | Recall initiated by company | |
| 23 Feb 2022 | Published in enforcement report | +15 days |
| 28 Feb 2022 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Where it was distributed
Product was distributed nationwide in the USA via Amazon Marketplace
Stores named: Amazon
Questions about this recall
Is RED Mammoth capsules, 400 mg recalled?
Yes. Celebrate Today recalled RED Mammoth capsules, 400 mg on 8 Feb 2022. The recall is Class I and its status is Terminated. Recall number D-0638-2022.
Why was it 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.
Which lots are affected?
Lot # DK1027, Exp. 08/01/2023
Where was it sold?
Product was distributed nationwide in the USA via Amazon Marketplace
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.