FDAClass IMarch 2, 2022

Rise UP RED Edition Capsules recall

RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.

Why was Rise UP RED Edition Capsules 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 48658908, Exp. date 09/09/2023

Product
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Recalling firm
Positive Health
Quantity
5,500 cartons
Distribution
Product was distributed nationwide via the internet through Amazon Marketplace.
Recall date
March 2, 2022
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls