TESTO-100 CIII (testosterone 100 mg) recall
FDA recall D-0258-2026 · initiated Oct 3, 2025
Advanced Pharmaceutical Technology, Inc. recalled TESTO-100 CIII (testosterone 100 mg) in Oct 2025 — an FDA Class II recall (D-0258-2026) because Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 22,843 pellets
Details
- 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
- Recalling company
- Advanced Pharmaceutical Technology, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
- Initiated
- Oct 3, 2025
- FDA report date
- Jan 21, 2026
Frequently asked
- Was TESTO-100 CIII (testosterone 100 mg) recalled?
- Advanced Pharmaceutical Technology, Inc. recalled TESTO-100 CIII (testosterone 100 mg) in Oct 2025 — an FDA Class II recall (D-0258-2026) because Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was TESTO-100 CIII (testosterone 100 mg) recalled?
- Per the FDA enforcement record, the reason for recall D-0258-2026 was: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
- Is a recalled TESTO-100 CIII (testosterone 100 mg) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of TESTO-100 CIII (testosterone 100 mg) are affected?
- Distributed: GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece. The recall covers these lots — Lot #: P-22-3, Exp 06-2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0258-2026.