CLASS II ONGOING Drug recall · Reported 2 Aug 2023 · FDA Enforcement Report
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL recalled
New Vitalis Pharmacy is recalling Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded, distributed nationwide in the US. The recall was initiated on 13 Jul 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-0944-2023
- FDA event ID
- 92699
- Recalling firm
- New Vitalis Pharmacy, Louisville, KY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2023
- FDA classified
- 24 Jul 2023
- Reported
- 2 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Jul 2023 | Recall initiated by company | |
| 24 Jul 2023 | Classified by FDA | +11 days |
| 2 Aug 2023 | 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 Assurance of Sterility
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-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: AL-05222023@901, BUD 7/22/23; AL-06122023@908CS, BUD 8/11/23
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.
More recalls from New Vitalis Pharmacy
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Testosterone Cypionate Testosterone Propionate, 180mg/mL recalled | New Vitalis Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate 180 mg/mL/Testosterone Propionate recalled | New Vitalis Pharmacy | Sterility | Nationwide |