TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose via… recall
FDA recall D-0531-2025 · initiated May 30, 2025
Advanced Pharmaceutical Technology, Inc. recalled TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml mul… in May 2025 — an FDA Class II recall (D-0531-2025) because Marketed Without an Approved NDA/ANDA.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Marketed Without an Approved NDA/ANDA
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
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: 26 vials
Details
- Product
- 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
- Recalling company
- Advanced Pharmaceutical Technology, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- NY, NJ
- Initiated
- May 30, 2025
- FDA report date
- Jul 2, 2025
Frequently asked
- Was TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml mul… recalled?
- Advanced Pharmaceutical Technology, Inc. recalled TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml mul… in May 2025 — an FDA Class II recall (D-0531-2025) because Marketed Without an Approved NDA/ANDA. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml mul… recalled?
- Per the FDA enforcement record, the reason for recall D-0531-2025 was: Marketed Without an Approved NDA/ANDA
- Is a recalled TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml mul… 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-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml mul… are affected?
- Distributed: NY, NJ. The recall covers these lots — Lot P-24-1; Exp. 02/28/2027. 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-0531-2025.