New Vitalis Pharmacy recalls testosterone injections due to lack of sterility assurance
New Vitalis Pharmacy recalls testosterone injections compounded in cottonseed oil due to lack of sterility assurance. Affected lots from July 2023 have a risk of infection.
Recall notice
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
New Vitalis Pharmacy is recalling testosterone injections that may not be sterile, which could lead to infections. This recall affects specific lots made between July 2023 and August 2023. Read more at govinfonow.com/recall/33375-new-vitalis-pharmacy-recalls-testosterone-injections-due-to-lack-of.
Source Summary by GovInfoNow · govinfonow.com/recall/33375-new-vitalis-pharmacy-recalls-testosterone-injections-due-to-lack-of · Updated September 23, 2026 · FDA enforcement record: FDA #D-0944-2023
Cite this page
“New Vitalis Pharmacy recalls testosterone injections due to lack of sterility assurance.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33375-new-vitalis-pharmacy-recalls-testosterone-injections-due-to-lack-of. Based on FDA recall #D-0944-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0944-2023%22&limit=1).
Why it’s dangerous
The injections were compounded in cottonseed oil without proper sterility assurance, which means they could be contaminated with bacteria. This contamination could cause infections if injected into the body.
Who’s affected
People who received the recalled testosterone injections from New Vitalis Pharmacy in Louisville, Kentucky, between July and August 2023 are affected. Those using the product for intramuscular injections are most at risk.
How to tell if you have this one
Check the product label for the lot numbers AL-05222023@901 (BUD 7/22/23) or AL-06122023@908CS (BUD 8/11/23). The product is a testosterone injection for intramuscular use only.
- Brand
New Vitalis Pharmacy- Category
Drug
What to do — step by step
Check Product Label
Look for the lot numbers AL-05222023@901 or AL-06122023@908CS on the vial.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0944-2023 (July 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0944-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.