CLASS III Drug recall · Reported 3 Feb 2021 · FDA Enforcement Report
Testosterone Cypionate Injection recalled
SUN Pharmaceutical Industries is recalling Testosterone Cypionate Injection, USP Ciii 200mg/ml For Intramuscular Use Only Single-dose, distributed nationwide in the US. The recall was initiated on 11 Jan 2021 and the FDA has classified it as Class III.
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-0242-2021
- FDA event ID
- 87168
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Jan 2021
- FDA classified
- 24 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Jan 2021 | Recall initiated by company | |
| 24 Jan 2021 | Classified by FDA | +13 days |
| 3 Feb 2021 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect Labeling: Incorrect lot number on secondary packaging
Product as listed by the FDA
Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Incorrect Labeling: Incorrect lot number on secondary packaging
Which lots are affected?
Lot JKX2553A
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 SUN Pharmaceutical Industries
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | 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 |