Ganciclovir recalls

The FDA has published 4 recalls involving Ganciclovir since 2014. The latest was reported on 4 Jan 2023. Most were for sterility. Hikma Pharmaceuticals USA 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

Ongoing0latest 4 Jan 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why ganciclovir is recalled

Sterility375%
Labeling Errors125%

Companies

By year

2023125%
2016125%
2015125%
2014125%

All ganciclovir recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
4 Jan 2023Drug	CLASS II	Ganciclovir for Injection, USP, 500mg per vial recalledGanciclovir	Hikma Pharmaceuticals USA	Labeling Errors	Nationwide
3 Feb 2016Drug	CLASS II	Ganciclovir in NS, Packaged as a) 320MG in Homepumps recalled	Sentara Enterprises	Sterility	NC, VA
8 Jul 2015Drug	CLASS II	Ganciclovir Sodium, 250MG / NS, QTY recalled by Lincare	Lincare	Sterility	AR
12 Nov 2014Drug	CLASS II	Ganciclovir, preservative free, 0.2mg recalled	Oregon Compounding Centers	Sterility	OR, WA

Should you stop taking Ganciclovir?

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.