Recall archive / FDA drug enforcement
Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio ... — FDA record D-0133-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 14, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
- Reason
- CGMP Deviations: Potential presence of metal particulate matter
- Classification
- Class II
- Recalling firm
- FARMAKEIO OUTSOURCING LLC
- Quantity
- 64,924 pellets
- Agency-reported status
- Ongoing
- Source record identifier
- D-0133-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot: 3091, 3096, Exp 1/7/2026; 3097, Exp 1/7/2026; 3182, 3186, 3187, 3188, Exp 2/10/2026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide in the USA and Antigua
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 5, 2025
- Recall initiation date
- Oct 14, 2025
- Center classification date
- Oct 29, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.