Why it was recalled
CGMP Deviations: Potential presence of metal particulate matter
Product description
Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
Lot numbers, UPCs & expiration codes
Lot, expiry: 3098, 3101, Exp 1/8/2026; 3107, Exp 1/13/2026; 3108, Exp 1/14/2026; 3109, Exp 1/15/2026; 3230, Exp 3/10/2026; 3231, Exp 3/11/2026; 3235, Exp 3/13/2026; 3236, Exp 3/17/2026; 3241, Exp 3/17/2026; 3242, Exp 3/18/2026.
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-0136-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 14, 2025
- FDA report date
- Nov 5, 2025
- Quantity
- 103,444 pellets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FARMAKEIO OUTSOURCING LLC
Original FDA data
Every field from FDA enforcement report D-0136-2026, 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, expiry: 3098, 3101, Exp 1/8/2026; 3107, Exp 1/13/2026; 3108, Exp 1/14/2026; 3109, Exp 1/15/2026; 3230, Exp 3/10/2026; 3231, Exp 3/11/2026; 3235, Exp 3/13/2026; 3236, Exp 3/17/2026; 3241, Exp 3/17/2026; 3242, Exp 3/18/2026.
- Postal code
- 76092-9019
- Report date
- Nov 5, 2025
- Product type
- Drugs
- Recall number
- D-0136-2026
- Classification
- Class II
- Recalling firm
- FARMAKEIO OUTSOURCING LLC
- Product quantity
- 103,444 pellets
- Reason for recall
- CGMP Deviations: Potential presence of metal particulate matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
- Distribution pattern
- Nationwide in the USA and Antigua
- Recall initiation date
- Oct 14, 2025
- Initial firm notification
- Center classification date
- Oct 29, 2025