FDA Drug recall D-1154-2022
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries,…
- FDA Drug
- Class II
- terminated
- Published 2022-06-29
On 2022-06-29 the FDA classified a Class II recall of Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries,… by Sun Pharmaceutical Industries, citing lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1154-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-10 |
| Published | 2022-06-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Identifiers
| ndc | 62756-017-40 |
|---|---|
| ndc | 62756-015-40 |
| ndc | 62756-016-40 |
| code_info | Lot: HAC3427A, EXP Date: 08/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1154-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.