CLASS II ONGOING Drug recall · Reported 2 Jul 2025 · FDA Enforcement Report
Testo-200, Testosterone Cypionate Inj recalled
Advanced Pharmaceutical Technology is recalling Testo-200, Testosterone Cypionate Inj, distributed in New Jersey, New York. The recall was initiated on 30 May 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-0531-2025
- FDA event ID
- 96981
- Recalling firm
- Advanced Pharmaceutical Technology, Elmsford, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 May 2025
- FDA classified
- 16 Jul 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 30 May 2025 | Recall initiated by company | |
| 2 Jul 2025 | Published in enforcement report | +33 days |
| 16 Jul 2025 | Classified by FDA | +14 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without an Approved NDA/ANDA
Product as listed by the FDA
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
Where it was distributed
NY, NJ
Questions about this recall
Why was it recalled?
Marketed Without an Approved NDA/ANDA
Which lots are affected?
Lot P-24-1; Exp. 02/28/2027
Where was it sold?
NY, NJ
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 26 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-100 Ciii (testosterone 100 mg), 10 Sterile Pellets recalled | Advanced Pharmaceutical Technology | Sterility | 4 states |