CLASS I Drug recall · Reported 20 Sep 2017 · FDA Enforcement Report
STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en recalled
Andropharm is recalling Andropharm Sten Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and, distributed in Florida. The recall was initiated on 6 Jun 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-1142-2017
- FDA event ID
- 77664
- Recalling firm
- Andropharm, Boca Raton, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Jun 2017
- FDA classified
- 12 Sep 2017
- Reported
- 20 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 6 Jun 2017 | Recall initiated by company | |
| 12 Sep 2017 | Classified by FDA | +98 days |
| 20 Sep 2017 | Published in enforcement report | +8 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 label states it contains anabolic steroids.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8
Where it was distributed
Florida
Questions about this recall
Is STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a recalled?
Yes. Andropharm recalled STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a on 6 Jun 2017. The recall is Class I and its status is Terminated. Recall number D-1142-2017.
Why was it recalled?
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Florida
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 Andropharm
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | M1 Alpha (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule recalled | Andropharm | Packaging Defects | FL |