Gemcitabine recalls

The FDA has published 6 recalls involving Gemcitabine since 2014. The latest was reported on 8 Jul 2026. Most were for particulate matter. Mylan Institutional 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 recalls6since 2014

Last 12 months1reported

Class I350% of total

Ongoing1latest 8 Jul 2026

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 1Jul 0 0

Severity split

Class I 3 50%Class II 3 50%Class III 0 0%

Why gemcitabine is recalled

Companies

By year

2026117%
2021117%
2015350%
2014117%

Ongoing gemcitabine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	Gemcitabine Injection per (38 mg/mL) Single-Dose Vial recalledGemcitabine	McKesson	Temperature Abuse	Nationwide

All gemcitabine recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	Gemcitabine Injection per (38 mg/mL) Single-Dose Vial recalledGemcitabine	McKesson	Temperature Abuse	Nationwide
2 Jun 2021Drug	CLASS II	Gemcitabine Injection 200mg recalled by Cardinal Health	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
26 Aug 2015Drug	CLASS I	Gemcitabine for Injection, USP*/vial, Lyophilized powder recalled	Mylan Institutional	Particulate Matter	Nationwide
26 Aug 2015Drug	CLASS I	Gemcitabine for Injection, USP, 200 mg*/vial recalled	Mylan Institutional	Particulate Matter	Nationwide
26 Aug 2015Drug	CLASS I	Gemcitabine for Injection, USP*/vial, Lyophilized powder recalled	Mylan Institutional	Particulate Matter	Nationwide
2 Jul 2014Drug	CLASS II	Gemcitabine For Injection USP, (lyophilized) recalled	Caraco Pharmaceutical Laboratories	Lead & Heavy Metals	OH

Should you stop taking Gemcitabine?

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.