FDA Drugs recall ·
Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG… recall
- Recall number
- D-0134-2026
- Date
- (initiated October 14, 2025)
- Company / brand
- Farmakeio Outsourcing LLC
920 S Kimball Ave Ste 100, Southlake, TX, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 31,124 pellets
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
CGMP Deviations: Potential presence of metal particulate matter
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 3090, Exp 1/7/2026; 3181, Exp 2/11/2026; 3189, 3190, Exp 2/12/2026
Distribution
Nationwide in the USA and Antigua
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0134-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.