FDA Drug recall D-0489-2023
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dos…
- FDA Drug
- Class II
- terminated
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dos… by Azurity Pharmaceuticals, citing cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0489-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-15 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Azurity Pharmaceuticals |
| Distribution | US |
Product
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.
Reason
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Identifiers
| ndc | 52536-625-01 |
|---|---|
| ndc | 52536-625-10 |
| code_info | Lot #23804.034A, 23803.061A, Exp 9/2024 |
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-0489-2023%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.