CLASS II Drug recall · Reported 4 Jan 2023 · FDA Enforcement Report
Ganciclovir for Injection, USP, 500mg per vial recalled
Hikma Pharmaceuticals USA is recalling Ganciclovir for Injection, USP, 500mg per vial, distributed nationwide in the US. The recall was initiated on 16 Dec 2022 and the FDA has classified it as Class II.
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-0090-2023
- FDA event ID
- 91333
- Recalling firm
- Hikma Pharmaceuticals USA, Cherry Hill, NJ
- Brand
- Ganciclovir
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Dec 2022
- FDA classified
- 27 Dec 2022
- Reported
- 4 Jan 2023
- Type
- Voluntary: Firm initiated
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Dec 2022 | Recall initiated by company | |
| 27 Dec 2022 | Classified by FDA | +11 days |
| 4 Jan 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Product as listed by the FDA
Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Which lots are affected?
Lot#: BQ0006, Exp 08/2023
Where was it sold?
USA Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Hikma Pharmaceuticals USA
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ramipril Capsules USP, 10 mg recalled by Hikma Pharmaceuticals USARamipril | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | Nationwide |
Other Ganciclovir recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ganciclovir in NS, Packaged as a) 320MG in Homepumps recalled | Sentara Enterprises | Sterility | NC, VA |
| Drug | CLASS II | Ganciclovir Sodium, 250MG / NS, QTY recalled by Lincare | Lincare | Sterility | AR |
| Drug | CLASS II | Ganciclovir, preservative free, 0.2mg recalled | Oregon Compounding Centers | Sterility | OR, WA |