Drug recall: ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-
FDA enforcement event 77664 is a drug recall by Andropharm, LLC of Boca Raton, FL, initiated 6 Jun 2017 and classified Class I, with 2 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 2 Jun 2020. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Andropharm, LLC.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Andropharm, LLC, Boca Raton, FL.
Reason for recall
"Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids."
Distribution
"Florida"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1142-2017 | 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 | 150 bottles | Class I | Terminated | 20 Sep 2017 |
| D-1143-2017 | ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4 | 1250 bottles | Class I | Terminated | 20 Sep 2017 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Florida"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.