New Vitalis Pharmacy recalls testosterone vials due to lack of sterility assurance
New Vitalis Pharmacy recalls specific testosterone vials (180mg/mL and 20mg/mL) for lack of sterility assurance. Affected lots expired by September 2021. Consumers should contact pharmacy for details.
Recall notice
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
New Vitalis Pharmacy is recalling testosterone vials that may not be sterile. This could lead to infections if used improperly. The recall affects specific lots with expiration dates through October 2021. Read more at govinfonow.com/recall/35841-new-vitalis-pharmacy-recalls-testosterone-vials-due-to-lack-of.
Source Summary by GovInfoNow · govinfonow.com/recall/35841-new-vitalis-pharmacy-recalls-testosterone-vials-due-to-lack-of · Updated August 18, 2026 · FDA enforcement record: FDA #D-0899-2021
Cite this page
“New Vitalis Pharmacy recalls testosterone vials due to lack of sterility assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35841-new-vitalis-pharmacy-recalls-testosterone-vials-due-to-lack-of. Based on FDA recall #D-0899-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0899-2021%22&limit=1).
Why it’s dangerous
The vials lack assurance of sterility, meaning they might contain harmful bacteria or other contaminants. If injected, this could cause serious infections or other health issues.
Who’s affected
People with prescriptions for testosterone injections from New Vitalis Pharmacy in Louisville, KY. Those using the recalled vials are at risk of infection due to potential contamination.
How to tell if you have this one
Check for vials labeled with lot numbers AL07202021 through AL08242021 and expiration dates up to October 2021. The product is prescription-only and sold at New Vitalis Pharmacy in Louisville, KY.
- Brand
New Vitalis Pharmacy- Category
Drug
What to do — step by step
Contact Pharmacy
Reach out to New Vitalis Pharmacy at 4139 Cadillac Ct, Louisville, KY 40213 for specific lot information and instructions.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0899-2021 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0899-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.