Recalls / Class II
Class IID-0258-2026
Product
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
- Affected lot / code info
- Lot #: P-22-3, Exp 06-2027
Why it was recalled
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Recalling firm
- Firm
- Advanced Pharmaceutical Technology, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 132 S Central Ave, Elmsford, New York 10523-3509
Distribution
- Quantity
- 22,843 pellets
- Distribution pattern
- GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
Timeline
- Recall initiated
- 2025-10-03
- FDA classified
- 2026-01-14
- Posted by FDA
- 2026-01-21
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0258-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.