Gilead Recalls Vistide Injection Due to Particulate Matter
Gilead Sciences recalls specific lots of Vistide (cidofovir) injection due to particulate matter. Check your vial's lot number and expiration date immediately.
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Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
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What happened, in plain English
Gilead Sciences, Inc. is recalling a small quantity of Vistide (cidofovir) Injection because particulate matter was found in some of the single-use vials. The recall affects 3,181 vials distributed nationwide in the USA, as well as to Canada and several European countries. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/48355-gilead-sciences-inc-recalls-vistide-cidofovir-injection-375-mg-75.
Source Summary by GovInfoNow · govinfonow.com/recall/48355-gilead-sciences-inc-recalls-vistide-cidofovir-injection-375-mg-75 · Updated October 13, 2026 · FDA enforcement record: FDA #D-324-2013
Cite this page
“Gilead Recalls Vistide Injection Due to Particulate Matter.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48355-gilead-sciences-inc-recalls-vistide-cidofovir-injection-375-mg-75. Based on FDA recall #D-324-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-324-2013%22&limit=1).
Why it’s dangerous
The presence of particulate matter in an injectable drug can pose serious health risks if introduced into the body, potentially causing blockages or inflammatory reactions at the injection site or in blood vessels.
Who’s affected
Patients prescribed Vistide (cidofovir) Injection who purchased or received vials from the specific lots listed below. Healthcare providers administering this medication are also affected.
How to tell if you have this one
Look for Vistide (cidofovir) Injection, 375 mg (75 mg/mL), in a 5 mL single-use vial. Check for Lot # B120217A with an expiration date of 05/15. The NDC is 61958-0101-1 and the UPC is 3 61958 01011 5.
- Brand
Gilead Sciences- Product
Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences- Category
Drug
What to do — step by step
Check Your Vial
Verify if your vial matches Lot # B120217A, NDC 61958-0101-1, and UPC 3 61958 01011 5.
Contact Your Provider
If you have the recalled vial, contact your healthcare provider or pharmacist for guidance on what to do next.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product distributed?
It was distributed nationwide in the USA, Canada, and the UK. Vials from the Cork, Ireland facility were also distributed to Germany, Austria, Italy, and Spain.
How many vials are affected by this recall?
A total of 3,181 vials are included in this recall.
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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-324-2013 (January 31, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-324-2013 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.