CLASS II Drug recall · Reported 18 Sep 2013 · FDA Enforcement Report
Testosterone Cypionate (Sesame Oil) 200mg/mL Injection Vial recalled
University Compounding Pharmacy is recalling Testosterone Cypionate (Sesame Oil) 200mg/mL Injection Vial, University Compounding, distributed nationwide in the US. The recall was initiated on 6 Sep 2013 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-1020-2013
- FDA event ID
- 66206
- Recalling firm
- University Compounding Pharmacy, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2013
- FDA classified
- 12 Sep 2013
- Reported
- 18 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Sep 2013 | Recall initiated by company | |
| 12 Sep 2013 | Classified by FDA | +6 days |
| 18 Sep 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Which lots are affected?
Lot 511017, Exp 11/30/2013
Where was it sold?
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.
Other products in this recall event
4 other products · FDA event 66206This product is part of a recall event; the main page for the event is Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL recalled | University Compounding Pharmacy | Sterility | Nationwide | |
| CLASS II | PGE-1, 20 mcg/mL Injection in Normal Saline recalled | University Compounding Pharmacy | Sterility | Nationwide | |
| CLASS II | PGE-1, 100 mcg/mL Injection in Normal Saline recalled | University Compounding Pharmacy | Sterility | Nationwide | |
| CLASS II | Testosterone CYP (Sesame Oil) 200mg/mL Injection Vial recalled | University Compounding Pharmacy | Sterility | Nationwide |
More recalls from University Compounding Pharmacy
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone CYP (Sesame Oil) 200mg/mL Injection Vial recalled | University Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | PGE-1, 100 mcg/mL Injection in Normal Saline recalled | University Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | PGE-1, 20 mcg/mL Injection in Normal Saline recalled | University Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL recalled | University Compounding Pharmacy | Sterility | Nationwide |
Other Testosterone Cypionate (sesame Oil recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate Injection (Sesame Oil), 200mg/mL vial recalled | Downing Labs | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate (Sesame Oil/Cmpd), 200mg/mL recalled | Oregon Compounding Centers | Sterility | OR, WA |
| Drug | CLASS II | Testosterone Cypionate (Sesame Oil) 200mg/mL recalled | South Coast Specialty Compounding | Sterility | CA, IN |