Testosterone Cypionate Injection — Class II drug recall D-0977-2018
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2018-08-01, distributed nationwide. Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
| Recall number | D-0977-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2018-07-12 |
| Classified | 2018-07-24 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2019-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 5,215 units |
| Reason classes | specification failure |
| NDC | 62756-0015, 62756-0015-40, 62756-0016, 62756-0016-40, 62756-0017, 62756-0017-40 |
| Lot numbers | JKS0280A |
| Expiration dates | 2019-06 |
Product
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
Reason for recall
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
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-0977-2018. 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.