FDA Drug recall D-0638-2022
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5
- FDA Drug
- Class I
- terminated
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class I recall of RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5 by Celebrate Today, citing 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 sexua….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0638-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-02-08 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Celebrate Today |
| Distribution | US |
Product
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Reason
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.
Identifiers
| code_info | Lot # DK1027, Exp. 08/01/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0638-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.