Testosterone Cypionate Injection — Class II drug recall D-0489-2023
Terminated recall by Azurity Pharmaceuticals, Inc., reported 2023-04-12, distributed nationwide. cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
| Recall number | D-0489-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Azurity Pharmaceuticals, Inc., Wilmington, MA, United States |
| Recall initiated | 2023-02-15 |
| Classified | 2023-03-31 |
| Reported by FDA | 2023-04-12 |
| Terminated | 2023-12-04 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 52536-0625, 52536-0625-01, 52536-0625-10 |
| Lot numbers | 23803.061A, 23804.034A |
| Expiration dates | 2024-09 |
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 for recall
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
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-0489-2023. 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.