CLASS II Drug recall · Reported 13 Jul 2022 · FDA Enforcement Report
Testosterone Cypionate Injection, USP, 200mg/ml recalled
SUN Pharmaceutical Industries is recalling Testosterone Cypionate Injection, USP, 200mg/ml, distributed nationwide in the US. The recall was initiated on 3 Jun 2022 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-1176-2022
- FDA event ID
- 90412
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2022
- FDA classified
- 7 Jul 2022
- Reported
- 13 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Jun 2022 | Recall initiated by company | |
| 7 Jul 2022 | Classified by FDA | +34 days |
| 13 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Product as listed by the FDA
Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Where it was distributed
nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Which lots are affected?
Lots JKX3267A & JKX3686A Exp. Date 08/2022 Lot JKX4700A, Exp Date 10/2022 Lot JKX5727A, Exp date 11/2022
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 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.
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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 |