AvKARE Recalls Famciclovir 500mg Due to Impurities
AvKARE recalls specific lots of Famciclovir tablets due to failed impurity specifications. Check your medication lot number and expiration date for details.
Use caution until it’s fixed
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Contact the company
What happened, in plain English
AvKARE Inc. is recalling Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons because the product contained unknown impurities above specification levels. The recall affects a small quantity of 116 cartons distributed nationwide. No specific remedy or return instructions are provided in the record. Read more at govinfonow.com/recall/41955-avkare-recalls-famciclovir-500mg-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/41955-avkare-recalls-famciclovir-500mg-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0610-2017
Cite this page
“AvKARE Recalls Famciclovir 500mg Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41955-avkare-recalls-famciclovir-500mg-due-to-impurities. Based on FDA recall #D-0610-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0610-2017%22&limit=1).
Why it’s dangerous
The product failed impurity specifications because it contained unknown impurities above the allowed limits. While the record does not specify the exact health consequences of these impurities, deviations in pharmaceutical purity can affect safety or efficacy.
Who’s affected
Patients who have been prescribed Famciclovir tablets, 500 mg, from AvKARE Inc. and possess the specific lot number and expiration date listed below are affected by this recall.
How to tell if you have this one
Check your medication for the brand AvKARE, NDC 50268-307-13, Lot #15152, and an expiration date of 02/2018. The product is packaged in 30-count unit dose cartons.
- Brand
AvKARE- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Famciclovir tablets match NDC 50268-307-13, Lot #15152, and Exp. 02/2018.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine the appropriate next steps for this specific lot.
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 5.3 years 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-0610-2017 (February 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0610-2017 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.