Testosterone Cypionate Injection — Class II drug recall D-1153-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-06-29, distributed nationwide. CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to
| Recall number | D-1153-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-06-03 |
| Classified | 2022-06-21 |
| Reported by FDA | 2022-06-29 |
| Terminated | 2023-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 97,450 vials |
| Reason classes | cgmp, specification failure |
| NDC | 62756-0015, 62756-0015-40, 62756-0016, 62756-0016-40, 62756-0017, 62756-0017-40 |
| Expiration dates | 2023-06 |
Product
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Reason for recall
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1153-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.