Testosterone Cypionate Injection — Class II drug recall D-1154-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-06-29, distributed nationwide. Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
| Recall number | D-1154-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-06-10 |
| Classified | 2022-06-22 |
| Reported by FDA | 2022-06-29 |
| Terminated | 2023-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 47,500 vials |
| Reason classes | microbial contamination, sterility |
| NDC | 62756-0015, 62756-0015-40, 62756-0016, 62756-0016-40, 62756-0017, 62756-0017-40 |
| Lot numbers | HAC3427A |
| Expiration dates | 2023-08 |
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
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
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-1154-2022. 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.