CLASS II Drug recall · Reported 24 Apr 2019 · FDA Enforcement Report
Testosterone Cypionate Injection, USP, 1000 mg/ (100 mg/mL) recalled
InvaGen Pharmaceuticals is recalling Testosterone Cypionate Injection, USP, 1000 mg/ (100 mg/mL), For intramuscular use only, distributed nationwide in the US. The recall was initiated on 22 Mar 2019 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-1125-2019
- FDA event ID
- 82463
- Recalling firm
- InvaGen Pharmaceuticals, Central Islip, NY
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Mar 2019
- FDA classified
- 15 Apr 2019
- Reported
- 24 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Mar 2019 | Recall initiated by company | |
| 15 Apr 2019 | Classified by FDA | +24 days |
| 24 Apr 2019 | 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
Presence of Particulate Matter.
Product as listed by the FDA
Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37.
Where it was distributed
Nationwide in the U.S.A.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter.
Which lots are affected?
Lots #: GH80216 Exp 1/2020; GH80322, GH80323 Exp 2/2020; GH90072 Exp 12/2020.
Where was it sold?
Nationwide in the U.S.A.
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.
Other products in this recall event
2 other products · FDA event 82463| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Testosterone Cypionate Injection, USP, 2000 mg/ (200 mg/mL) recalledTestosterone Cypionate | InvaGen Pharmaceuticals | Particulate Matter | Nationwide | |
| CLASS II | Testosterone Cypionate Injection, USP, 200 mg/mL recalledTestosterone Cypionate | InvaGen Pharmaceuticals | Particulate Matter | Nationwide |
More recalls from InvaGen Pharmaceuticals
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets recalledVigabatrin | InvaGen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Gabapentin Tablets USP, 600 mg recalled by InvaGen PharmaceuticalsGabapentin | InvaGen Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Testosterone Topical Solution 30mg of testosterone per pump recalledTestosterone | InvaGen Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 200 mg/mL recalledTestosterone Cypionate | InvaGen Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, 2000 mg/ (200 mg/mL) recalledTestosterone Cypionate | InvaGen Pharmaceuticals | Particulate Matter | Nationwide |
Other Testosterone Cypionate recalls
All 130| 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, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | 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/Enanthate 100/100mg/ml, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |