Vistide — Class I drug recall D-324-2013
Terminated recall by Gilead Sciences, Inc., reported 2013-05-22, distributed nationwide. Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
| Recall number | D-324-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gilead Sciences, Inc., Foster City, CA, United States |
| Recall initiated | 2013-01-31 |
| Classified | 2013-05-16 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2014-01-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, DE, ES, GB, IE, IT |
| Quantity | 3,181 vials |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00361958010115 |
| NDC | 61958-0101-01 |
| Lot numbers | 05/15US, B120217A |
Product
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.
Reason for recall
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-324-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.