FDA Recall D-0129-2026
FARMAKEIO OUTSOURCING LLC · Southlake, TX
Class II Ongoing 212 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
Reason for recall
CGMP Deviations: Potential presence of metal particulate matter
Recall record
- Recall number
D-0129-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in the USA and Antigua
- Recall initiated
- 2025-10-14
- Classified by FDA Center
- 2025-10-29
- FDA published
- 2025-11-05
- Recalling firm
- FARMAKEIO OUTSOURCING LLC
- Firm location
- Southlake, TX
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.