FDA Drug recall D-0258-2026
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 Sout…
- FDA Drug
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 Sout… by Advanced Pharmaceutical Technology, citing lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0258-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-03 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Pharmaceutical Technology |
| Distribution | GA, NY, PR, TX |
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
Reason
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Identifiers
| code_info | Lot #: P-22-3, Exp 06-2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0258-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.