Why it was recalled
CGMP Deviations: Potential presence of metal particulate matter
Product description
Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
Lot numbers, UPCs & expiration codes
Lot: 3090, Exp 1/7/2026; 3181, Exp 2/11/2026; 3189, 3190, Exp 2/12/2026
Where it was sold
Nationwide in the USA and Antigua
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0134-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 14, 2025
- FDA report date
- Nov 5, 2025
- Quantity
- 31,124 pellets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FARMAKEIO OUTSOURCING LLC
Original FDA data
Every field from FDA enforcement report D-0134-2026, exactly as published.
Show all FDA fields
- City
- Southlake
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 97799
- Address
- 920 S Kimball Ave Ste 100
- Code information
- Lot: 3090, Exp 1/7/2026; 3181, Exp 2/11/2026; 3189, 3190, Exp 2/12/2026
- Postal code
- 76092-9019
- Report date
- Nov 5, 2025
- Product type
- Drugs
- Recall number
- D-0134-2026
- Classification
- Class II
- Recalling firm
- FARMAKEIO OUTSOURCING LLC
- Product quantity
- 31,124 pellets
- Reason for recall
- CGMP Deviations: Potential presence of metal particulate matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
- Distribution pattern
- Nationwide in the USA and Antigua
- Recall initiation date
- Oct 14, 2025
- Initial firm notification
- Center classification date
- Oct 29, 2025