Testosterone Cypionate Injection recall
FDA recall D-0363-2025 · initiated Apr 10, 2025
Eugia US LLC recalled Testosterone Cypionate Injection in Apr 2025 — an FDA Class II recall (D-0363-2025) because cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
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: 36,816 vials
Details
- Product
- Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide USA
- Initiated
- Apr 10, 2025
- FDA report date
- Apr 23, 2025
Frequently asked
- Was Testosterone Cypionate Injection recalled?
- Eugia US LLC recalled Testosterone Cypionate Injection in Apr 2025 — an FDA Class II recall (D-0363-2025) because cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Testosterone Cypionate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0363-2025 was: cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
- Is a recalled Testosterone Cypionate Injection 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 Testosterone Cypionate Injection are affected?
- Distributed: Nationwide USA. The recall covers these lots — Lot #: 1TC24075A, Exp 11/30/2026.. 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-0363-2025.