FDA Drug recall D-0645-2022
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1
- FDA Drug
- Class I
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class I recall of RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1 by Positive Health, citing marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0645-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-02-10 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Positive Health |
| Distribution | US |
Product
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Reason
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Identifiers
| code_info | Lot # 48658908, Exp. date 09/09/2023 |
|---|
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-0645-2022%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.