CLASS II ONGOING Drug recall · Reported 21 Jan 2026 · FDA Enforcement Report
Testo-100 Ciii (testosterone 100 mg), 10 Sterile Pellets recalled
Advanced Pharmaceutical Technology is recalling Testo-100 Ciii (testosterone 100 mg), 10 Sterile Pellets per, distributed in Georgia, New York, Puerto Rico, Texas. The recall was initiated on 3 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0258-2026
- FDA event ID
- 97821
- Recalling firm
- Advanced Pharmaceutical Technology, Elmsford, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Oct 2025
- FDA classified
- 14 Jan 2026
- Reported
- 21 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Hormones & Birth Control
Timeline
| 3 Oct 2025 | Recall initiated by company | |
| 14 Jan 2026 | Classified by FDA | +103 days |
| 21 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
Questions about this recall
Is Testo-100 Ciii (testosterone 100 mg), 10 Sterile Pellets per recalled?
Yes. Advanced Pharmaceutical Technology recalled Testo-100 Ciii (testosterone 100 mg), 10 Sterile Pellets per on 3 Oct 2025. The recall is Class II and its status is Ongoing. Recall number D-0258-2026.
Why was it recalled?
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Which lots are affected?
Lot #: P-22-3, Exp 06-2027
Where was it sold?
GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Advanced Pharmaceutical Technology
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testo-200, Testosterone Cypionate Inj recalled | Advanced Pharmaceutical Technology | Other | NJ, NY |