CLASS II ONGOING Drug recall · Reported 5 Nov 2025 · FDA Enforcement Report
Testosterone 50MG, 1 Pellet (Sterile) For Subcutaneous Insertion recalled
Farmakeio Outsourcing is recalling Testosterone 50MG, 1 Pellet (Sterile) For Subcutaneous Insertion, distributed nationwide in the US. The recall was initiated on 14 Oct 2025 and the FDA has classified it as Class II.
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-0124-2026
- FDA event ID
- 97799
- Recalling firm
- Farmakeio Outsourcing, Southlake, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Oct 2025
- FDA classified
- 29 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Hormones & Birth Control
Timeline
| 14 Oct 2025 | Recall initiated by company | |
| 29 Oct 2025 | Classified by FDA | +15 days |
| 5 Nov 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Potential presence of metal particulate matter
Product as listed by the FDA
Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
Where it was distributed
Nationwide in the USA and Antigua
Questions about this recall
Is Testosterone 50MG, 1 Pellet (Sterile) For Subcutaneous Insertion recalled?
Yes. Farmakeio Outsourcing recalled Testosterone 50MG, 1 Pellet (Sterile) For Subcutaneous Insertion on 14 Oct 2025. The recall is Class II and its status is Ongoing. Recall number D-0124-2026.
Why was it recalled?
CGMP Deviations: Potential presence of metal particulate matter
Which lots are affected?
Lot 3179, EXP 02/17/2026
Where was it sold?
Nationwide in the USA and Antigua
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Farmakeio Outsourcing
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone 5 MG, 1 Pellet (Sterile) For Subcutaneous Insertion recalled | Farmakeio Outsourcing | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone Regular Release 200 MG, 1 Pellet recalled | Farmakeio Outsourcing | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone / Triamcinolone Acetonide, 5MG/12.5MCG recalled | Farmakeio Outsourcing | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone 200 MG, 1 Pellet (Sterile) For Subcutaneous Insertion recalled | Farmakeio Outsourcing | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 Pellet recalled | Farmakeio Outsourcing | Particulate Matter | Nationwide |