CLASS II ONGOING Drug recall · Reported 23 Apr 2025 · FDA Enforcement Report
Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalled
Eugia US is recalling Testosterone Cypionate Injection, USP, CIII, 200mg per mL, distributed nationwide in the US. The recall was initiated on 10 Apr 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-0363-2025
- FDA event ID
- 96680
- Recalling firm
- Eugia US, East Windsor, NJ
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Apr 2025
- FDA classified
- 14 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Apr 2025 | Recall initiated by company | |
| 14 Apr 2025 | Classified by FDA | +4 days |
| 23 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA
Questions about this recall
Is Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalled?
Yes. Eugia US recalled Testosterone Cypionate Injection, USP, CIII, 200mg per mL on 10 Apr 2025. The recall is Class II and its status is Ongoing. Recall number D-0363-2025.
Why was it recalled?
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Which lots are affected?
Lot #: 1TC24075A, Exp 11/30/2026.
Where was it sold?
Nationwide USA
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.
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Other Testosterone Cypionate recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate Injection, 200 mg/mL, CIII recalled | Empower Clinic Services | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate | Azurity Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 200mg/mL, CIII recalledTestosterone Cypionate | Sun Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 200mg/ml recalledTestosterone Cypionate | Sun Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection recalledTestosterone Cypionate | Sun Pharmaceutical Industries | Sterility | Nationwide |