# FDA recall D-0638-2022

> **Celebrate Today** · Class I · drug recall initiated 2022-02-08.

## Product

RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.

## 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.

## Distribution

Product was distributed nationwide in the USA via Amazon Marketplace

## Key facts

- **Recall number:** D-0638-2022
- **Recalling firm:** Celebrate Today
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-02-08
- **Report date:** 2022-02-23
- **Termination date:** 2022-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brentwood, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0638-2022

## Citation

> AI Analytics. FDA recall D-0638-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0638-2022. Source: US FDA. Licensed CC0.

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