Hikma Ganciclovir Injection Recall: Mislabeling Risk
Hikma Pharmaceuticals recalls Ganciclovir injection vials due to mislabeling with Cladribine. Affected units may contain incorrect labeling that could lead to medication errors.
Lower-risk recall
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
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What happened, in plain English
Hikma Pharmaceuticals is recalling Ganciclovir injection vials that were mislabeled as Cladribine. This mix-up could cause serious medication errors if the wrong drug is used. Read more at govinfonow.com/recall/34178-hikma-ganciclovir-injection-recall-mislabeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34178-hikma-ganciclovir-injection-recall-mislabeling-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0090-2023
Cite this page
“Hikma Ganciclovir Injection Recall: Mislabeling Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34178-hikma-ganciclovir-injection-recall-mislabeling-risk. Based on FDA recall #D-0090-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0090-2023%22&limit=1).
Why it’s dangerous
The vials were mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500mg. This mix-up could lead to using the wrong medication if the label is not checked carefully.
Who’s affected
Patients prescribed Ganciclovir injection by a doctor are affected. Those using the product without medical supervision are not at risk.
How to tell if you have this one
Check for vials labeled 'Cladribine Injection 10mg/mL' in a 10-count carton. The product was manufactured by Thymoorgan Pharma in Germany and distributed by Hikma in the US.
- Brand
Hikma- Category
Drug
What to do — step by step
Check Label Carefully
Ensure the label reads 'Ganciclovir Injection, USP, 500mg per vial' not 'Cladribine Injection 10mg/mL'.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months 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-0090-2023 (December 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0090-2023 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.