Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Product description
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
Nationwide in the US
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-0001-2022
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 16, 2021
- FDA report date
- Oct 13, 2021
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alpha-Tek LLC
Original FDA data
Every field from FDA enforcement report D-0001-2022, exactly as published.
Show all FDA fields
- City
- Tucson
- State
- AZ
- Status
- Ongoing
- Country
- United States
- Event ID
- 88335
- Address
- 3280 E Hemisphere Loop
- Address (line 2)
- Suite 190
- Code information
- All lots within expiry
- Postal code
- 85706-5023
- Report date
- Oct 13, 2021
- Product type
- Drugs
- Recall number
- D-0001-2022
- Classification
- Class I
- Recalling firm
- Alpha-Tek LLC
- Product quantity
- Unknown
- Reason for recall
- Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Jul 16, 2021
- Center classification date
- Oct 4, 2021