Recalls / Class II
Class IID-0125-2026
Product
Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
- Affected lot / code info
- Lot 3180, EXP 2/17/2026
Why it was recalled
CGMP Deviations: Potential presence of metal particulate matter
Recalling firm
- Firm
- FARMAKEIO OUTSOURCING LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 920 S Kimball Ave Ste 100, N/A, Southlake, Texas 76092-9019
Distribution
- Quantity
- 829 pellets
- Distribution pattern
- Nationwide in the USA and Antigua
Timeline
- Recall initiated
- 2025-10-14
- FDA classified
- 2025-10-29
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0125-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.