CLASS I Drug recall · Reported 22 May 2013 · FDA Enforcement Report
Vistide (cidofovir) Injection, 375 mg (75 mg/mL) single-use vial recalled
Gilead Sciences is recalling Vistide (cidofovir) Injection, 375 mg (75 mg/mL) single-use vial, distributed nationwide in the US. The recall was initiated on 31 Jan 2013 and the FDA has classified it as Class I.
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-324-2013
- FDA event ID
- 64267
- Recalling firm
- Gilead Sciences, Foster City, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 31 Jan 2013
- FDA classified
- 16 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 31 Jan 2013 | Recall initiated by company | |
| 16 May 2013 | Classified by FDA | +105 days |
| 22 May 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Product as listed by the FDA
Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1.
Where it was distributed
Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Which lots are affected?
Lot #: B120217A, Exp 05/15 - US Distribution
Where was it sold?
Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Gilead Sciences
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial recalledVeklury | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial recalledVeklury | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS II | Emtriva (emtricitabine) Oral Solution, 10 mg/mL recalled | Gilead Sciences | Packaging Defects | PR |
| Drug | CLASS III | Truvada (200 mg emtricitabine recalled by Gilead SciencesTruvada | Gilead Sciences | Particulate Matter | Nationwide |
| Drug | CLASS III | Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir recalled | Gilead Sciences | Particulate Matter | Nationwide |