Ibuprofen Lysine recalls

The FDA has published 1 recall involving Ibuprofen Lysine since 2017. The latest was reported on 12 Apr 2017. Most were for particulate matter. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2017

Last 12 months0reported

Class I1100% of total

Ongoing0latest 12 Apr 2017

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 1 100%Class II 0 0%Class III 0 0%

Why ibuprofen lysine is recalled

Particulate Matter1100%

Companies

X-Gen Pharmaceuticals1100%

By year

20171100%

All ibuprofen lysine recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
12 Apr 2017Drug	CLASS I	Ibuprofen Lysine Injection, 20 mg/ (10 mg/mL) Single-Dose Vial recalledIbuprofen Lysine	X-Gen Pharmaceuticals	Particulate Matter	Nationwide

Should you stop taking Ibuprofen Lysine?

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.