Class II · Moderate risk
Testosterone 100mg Anastrozole 4mg
Presence of Foreign substance - potential presence of metal particulate matter
Testo-100 Ciii
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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 NDC
57377-0100-01
Compare with the code on your package — it is the most precise check available.
Drug: Testosterone
- Recalling firm
- Advanced Pharmaceutical Technology, Inc.
- NDC code
- 57377-100-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0258-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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Class II · Moderate risk
Testosterone 87.5mg
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Class II · Moderate risk
Testosterone 200mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 75mg
Presence of Foreign substance - potential presence of metal particulate matter
Other recalls by Advanced Pharmaceutical Technology, Inc.
All 2025 recalls
Class II · Moderate risk
Testo-200
Marketed Without an Approved NDA/ANDA
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