PlainRecalls
FDA Drug Critical Class I Terminated

SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.

Reported: August 10, 2022 Initiated: July 21, 2022 #D-1350-2022

Product Description

SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.

Reason for Recall

Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.

Details

Recalling Firm
Ultra Supplement LLC
Units Affected
750 cartons
Distribution
Product was distributed nationwide in the USA via Amazon Marketplace on www.amazon.com.
Location
Wilmington, DE

Frequently Asked Questions

What product was recalled?
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.. Recalled by Ultra Supplement LLC. Units affected: 750 cartons.
Why was this product recalled?
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 10, 2022. Severity: Critical. Recall number: D-1350-2022.