XCEL Capsules recall
XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
Why was XCEL Capsules recalled?
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.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?
All lots
- Product
- XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
- Recalling firm
- Bee Extremely Amazed LLC
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- July 13, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)