Why it was recalled
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Product description
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
Lot numbers, UPCs & expiration codes
Lot DAP272109, Exp: 4/1/2026
Where it was sold
Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.
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-1350-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 21, 2022
- FDA report date
- Aug 10, 2022
- Quantity
- 750 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ultra Supplement LLC
Original FDA data
Every field from FDA enforcement report D-1350-2022, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 90659
- Address
- 1007 N Market St
- Code information
- Lot DAP272109, Exp: 4/1/2026
- Postal code
- 19801-1227
- Report date
- Aug 10, 2022
- Product type
- Drugs
- Recall number
- D-1350-2022
- Classification
- Class I
- Recalling firm
- Ultra Supplement LLC
- Product quantity
- 750 cartons
- Termination date
- Oct 16, 2023
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
- Distribution pattern
- Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.
- Recall initiation date
- Jul 21, 2022
- Initial firm notification
- Press Release
- Center classification date
- Aug 17, 2022