TESTO-100 CIII — Class II drug recall D-0258-2026
Ongoing recall by Advanced Pharmaceutical Technology, Inc., reported 2026-01-21, distributed in GA, NY, PR, TX. Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
| Recall number | D-0258-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advanced Pharmaceutical Technology, Inc., Elmsford, NY, United States |
| Recall initiated | 2025-10-03 |
| Classified | 2026-01-14 |
| Reported by FDA | 2026-01-21 |
| Distributed | GA, NY, PR, TX |
| Countries outside the US | GB, GR, MT |
| Quantity | 22,843 pellets |
| Reason classes | microbial contamination, sterility |
| NDC | 57377-0100-01 |
| Lot numbers | P-22-3 |
| Expiration dates | 2027-06 |
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 for recall
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0258-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.