CLASS II ONGOING Drug recall · Reported 5 Nov 2025 · FDA Enforcement Report
Testosterone 25MG, 1 Pellet (Sterile) For Subcutaneous Insertion recalled
Farmakeio Outsourcing is recalling Testosterone 25MG, 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-0123-2026
- 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 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
Where it was distributed
Nationwide in the USA and Antigua
Questions about this recall
Why was it recalled?
CGMP Deviations: Potential presence of metal particulate matter
Which lots are affected?
Lot 3294, EXP 4/8/2026
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 97799This product is part of a recall event; the main page for the event is Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 Pellet recalled.
More recalls from Farmakeio Outsourcing
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone 87.5 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, 62.5MG/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 |
Other Testosterone recalls
All 91| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone, 37.5 mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone, 50.0 mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone, 18.0 mg, 1 Sterile Pellet recalled | F.H. Investments Inc. ( | Particulate Matter | Nationwide |