CLASS II Drug recall · Reported 4 Dec 2019 · FDA Enforcement Report
Testosterone Cypionate 180 mg/mL/Testosterone Propionate recalled
New Vitalis Pharmacy is recalling Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, distributed nationwide in the US. The recall was initiated on 1 Oct 2019 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-0523-2020
- FDA event ID
- 84189
- Recalling firm
- New Vitalis Pharmacy, Louisville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2019
- FDA classified
- 25 Nov 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Oct 2019 | Recall initiated by company | |
| 25 Nov 2019 | Classified by FDA | +55 days |
| 4 Dec 2019 | Published in enforcement report | +9 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 sterility assurance.
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 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution recalled?
Yes. New Vitalis Pharmacy recalled Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution on 1 Oct 2019. The recall is Class II and its status is Terminated. Recall number D-0523-2020.
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lot, expiry: AL-07232019@99, exp 9-23-2019; AL-07312019@99, exp 9-30-2019; AL-08132019@99, exp 10-13-2019; AL-08272019@901, exp 10-27-2019; AL-08282019@909, exp 10-28-2019; Al-09032019@903, exp 11-3-2019
Where was it sold?
Distributed Nationwide in the USA
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 21 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 New Vitalis Pharmacy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL recalled | New Vitalis Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Testosterone Propionate, 180mg/mL recalled | New Vitalis Pharmacy | Sterility | Nationwide |