Famciclovir recalls

The FDA has published 4 recalls involving Famciclovir since 2014. The latest was reported on 16 Jul 2025. Most were for labeling errors. Macleods Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 16 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 1 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 3 75%Class III 1 25%

Why famciclovir is recalled

Companies

By year

2025125%
2018125%
2017125%
2014125%

Ongoing famciclovir recalls

1 active

Reported	Class	Recall	Company	Reason	Where
16 Jul 2025Drug	CLASS III	Famciclovir Tablets, USP 500 mg recalled by Macleods PharmaceuticalsFamciclovir	Macleods Pharmaceuticals	Packaging Defects	Nationwide

All famciclovir recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
16 Jul 2025Drug	CLASS III	Famciclovir Tablets, USP 500 mg recalled by Macleods PharmaceuticalsFamciclovir	Macleods Pharmaceuticals	Packaging Defects	Nationwide
21 Feb 2018Drug	CLASS II	Famciclovir Tablets, 500 mg recalled by Hetero Labs Limited Unit VFamciclovir	Hetero Labs Limited Unit V	Temperature Abuse	Nationwide
29 Mar 2017Drug	CLASS II	Famciclovir tablets, 500 mg recalled by AVKARE	Avkare	Potency & Assay	Nationwide
29 Jan 2014Drug	CLASS II	Famciclovir, Tablet, 500 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Famciclovir?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.