CLASS II Drug recall · Reported 9 Apr 2025 · FDA Enforcement Report
Voriconazole Tablets, 50 mg recalled by Amerisource Health Services
Amerisource Health Services is recalling Voriconazole Tablets, 50 mg, distributed nationwide in the US. The recall was initiated on 24 Mar 2025 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-0307-2025
- FDA event ID
- 96574
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Brand
- Voriconazole
- Manufacturer
- American Health Packaging
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Mar 2025
- FDA classified
- 28 Mar 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 24 Mar 2025 | Recall initiated by company | |
| 28 Mar 2025 | Classified by FDA | +4 days |
| 9 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Product as listed by the FDA
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.
Where it was distributed
USA nationwide.
Questions about this recall
Why was it recalled?
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
Which lots are affected?
Lot # 1014138, Exp 04/30/2025
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 Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Voriconazole recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Voriconazole Tablets 200 mg recalled by Glenmark PharmaceuticalsVoriconazole | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Voriconazole Tablets 50mg recalled by Glenmark PharmaceuticalsVoriconazole | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Voriconazole for Oral Suspension, 40mg/mL recalledVoriconazole | Lupin Pharmaceuticals | Packaging Defects | IL, NJ, OH |
| Drug | CLASS II | Voriconazole 10mg/ML Dropper) Oph Solution recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS III | Voriconazole Tablets, 200 mg cartons Dose recalled by AVKARE | Avkare | Potency & Assay | Nationwide |