Why it was 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.
Product description
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
Lot numbers, UPCs & expiration codes
Lot # 2010291, Exp 01/07/2024
Where it was sold
Product was distributed nationwide in the USA via Amazon Marketplace
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0557-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 4, 2022
- FDA report date
- Feb 16, 2022
- Quantity
- 750 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Junp Hydration LLC
Original FDA data
Every field from FDA enforcement report D-0557-2022, exactly as published.
Show all FDA fields
- City
- Brooklyn
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89543
- Address
- 1013 Mcdonald Ave
- Code information
- Lot # 2010291, Exp 01/07/2024
- Postal code
- 11230-1009
- Report date
- Feb 16, 2022
- Product type
- Drugs
- Recall number
- D-0557-2022
- Classification
- Class I
- Recalling firm
- Junp Hydration LLC
- Product quantity
- 750 cartons
- Termination date
- Jun 9, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
- Distribution pattern
- Product was distributed nationwide in the USA via Amazon Marketplace
- Recall initiation date
- Feb 4, 2022
- Initial firm notification
- Press Release
- Center classification date
- Feb 11, 2022