CLASS I Drug recall · Reported 23 Aug 2017 · FDA Enforcement Report
Ultra-sten Rapid Size and Strength capsules, 10 mgs recalled
Hardcore Formulations is recalling Ultra-sten Rapid Size and Strength capsules, 10 mgs, Hardcore Formulations, distributed nationwide in the US. The recall was initiated on 5 Jul 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1084-2017
- FDA event ID
- 77660
- Recalling firm
- Hardcore Formulations, San Marcos, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Jul 2017
- FDA classified
- 14 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 5 Jul 2017 | Recall initiated by company | |
| 14 Aug 2017 | Classified by FDA | +40 days |
| 23 Aug 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Product as listed by the FDA
ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
Where it was distributed
Nationwide
Questions about this recall
Is Ultra-sten Rapid Size and Strength capsules, 10 mgs, Hardcore Formulations recalled?
Yes. Hardcore Formulations recalled Ultra-sten Rapid Size and Strength capsules, 10 mgs, Hardcore Formulations on 5 Jul 2017. The recall is Class I and its status is Terminated. Recall number D-1084-2017.
Why was it recalled?
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hardcore Formulations
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | D-zine Rapid Size and Strength capsules, 10mgs recalled | Hardcore Formulations | Other | Nationwide |