Ketorolac recalls

The FDA has published 2 recalls involving Ketorolac since 2013. The latest was reported on 9 Dec 2015. Most were for sterility. Western Drug 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 recalls2since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 9 Dec 2015

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 2 100%Class III 0 0%

Why ketorolac is recalled

Sterility2100%

Companies

Western Drug150%
FVS Holdings150%

By year

2015150%
2013150%

All ketorolac recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
9 Dec 2015Drug	CLASS II	Ketorolac 40mg/mL Injection, Rx recalled by Western Drug	Western Drug	Sterility	Nationwide
22 May 2013Drug	CLASS II	Ketorolac Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide

Should you stop taking Ketorolac?

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.