AvKARE Recalls Voriconazole Tablets Due to Impurity Issues
AvKARE recalls specific lots of Voriconazole Tablets 200 mg because they failed impurity specifications. Check your lot numbers and expiration dates for details.
Recall notice
Failed impurities/degradation specifications: Out of specification for a related compound C.
Contact the company
What happened, in plain English
AvKARE Inc. is recalling Voriconazole Tablets, 200 mg, in 20-count cartons because the product failed to meet specifications for related compound C impurities. The recall affects 1,172 cartons distributed nationwide. No remedy or specific health risks are detailed in this record. Read more at govinfonow.com/recall/41434-avkare-recalls-voriconazole-tablets-due-to-impurity-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/41434-avkare-recalls-voriconazole-tablets-due-to-impurity-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-1094-2017
Cite this page
“AvKARE Recalls Voriconazole Tablets Due to Impurity Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41434-avkare-recalls-voriconazole-tablets-due-to-impurity-issues. Based on FDA recall #D-1094-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1094-2017%22&limit=1).
Why it’s dangerous
The recalled tablets failed impurity specifications for a related compound C. The record does not explain what this failure means for patient safety or if it causes harm.
Who’s affected
Consumers who purchased Voriconazole Tablets, 200 mg, from pharmacies nationwide between the manufacturing date and July 19, 2017, may be affected. Individuals using the specific lots listed are at potential risk due to impurity failures.
How to tell if you have this one
Look for Voriconazole Tablets, 200 mg, in 20-count cartons (4 x 5) Unit Dose. Check the NDC 50268-804-12 and lot numbers 16933 (Exp 07/2018) or 17054 (Exp 08/2018). The product was manufactured for AvKARE, Inc. in Pulaski, TN.
- Brand
AvKARE- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-1094-2017 (July 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1094-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.