CLASS II Drug recall · Reported 12 Apr 2023 · FDA Enforcement Report
Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalled
Azurity Pharmaceuticals is recalling Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, distributed nationwide in the US. The recall was initiated on 15 Feb 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0489-2023
- FDA event ID
- 91710
- Recalling firm
- Azurity Pharmaceuticals, Wilmington, MA
- Manufacturer
- Wilshire Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2023
- FDA classified
- 31 Mar 2023
- Reported
- 12 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Feb 2023 | Recall initiated by company | |
| 31 Mar 2023 | Classified by FDA | +44 days |
| 12 Apr 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Which lots are affected?
Lot #23804.034A, 23803.061A, Exp 9/2024
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Azurity Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS I | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg recalledZenzedi | Azurity Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Eprontia (topiramate) oral solution, 25 mg/mL recalledEprontia | Azurity Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Firvanq (vancomycin hydrochloride for oral solution) recalledFirvanq | Azurity Pharmaceuticals | Packaging Defects | Nationwide |
Other Testosterone Cypionate recalls
All 131| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate, 200 mg/mL recalled by Right Value Drug Stores | Right Value Drug Stores | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, 200 mg/mL, CIII recalled | Empower Clinic Services | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate | Eugia US | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |