Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
Class I · High risk Terminated Initiated Jul 5, 2017 (9 years ago)

ULTRA-STEN Rapid Size and Strength capsules

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.

Cause type: Unapproved drug

The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.

What was recalled

ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0

Recalling firm
Hardcore Formulations
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1084-2017 · FDA notice

Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Hardcore Formulations

All 2017 recalls

Other unapproved drug recalls from 2017

All unapproved drug recalls
Class III · Low risk

Gabapentin Oral Solution

CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.

Terminated Unapproved drug Akorn Inc D-0211-2018
Class III · Low risk

Meclizine hydrochloride tablets USP

Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

Terminated Unapproved drug Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-122-06 D-0082-2018