CLASS I Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report
Rise UP Red Edition Capsules, 650 mg blisters recalled
Positive Health is recalling Rise UP Red Edition Capsules, 650 mg blisters, distributed nationwide in the US. The recall was initiated on 10 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-0645-2022
- FDA event ID
- 89606
- Recalling firm
- Positive Health, Wilmington, DE
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Feb 2022
- FDA classified
- 4 Mar 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 10 Feb 2022 | Recall initiated by company | |
| 2 Mar 2022 | Published in enforcement report | +20 days |
| 4 Mar 2022 | Classified by FDA | +2 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 tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Product as listed by the FDA
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Where it was distributed
Product was distributed nationwide via the internet through Amazon Marketplace.
Stores named: Amazon, Online Retailers
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # 48658908, Exp. date 09/09/2023
Where was it sold?
Product was distributed nationwide via the internet through 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.