Ketorolac Tromethamine recalls

Ketorolac Tromethamine products have been recalled 18 times, most recently on 29 Oct 2025. The recalling company is usually Hospira. The most common reason is particulate matter.

Total recalls18since 2013

Last 12 months2reported

Class I317% of total

Ongoing5latest 29 Oct 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 2 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 3 17%Class II 15 83%Class III 0 0%

Why ketorolac tromethamine is recalled

Companies

Product types

Pain Medication18100%

By year

2025317%
202216%
2021211%
2020422%
201916%
2015528%
201416%
201316%

Ongoing ketorolac tromethamine recalls

5 active

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Injection, USP, 60 mg recalled by Aspiro PharmaKetorolac Tromethamine	Aspiro Pharma	Particulate Matter	Nationwide
8 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
22 Jul 2015Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 60 mg recalled by HospiraKetorolac Tromethamine	Hospira	Other	Nationwide
22 Jul 2015Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL) Fill recalledKetorolac Tromethamine	Hospira	Other	Nationwide

All ketorolac tromethamine recalls, newest first

18 total

Reported	Class	Recall	Company	Reason	Where
29 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Injection, USP, 60 mg recalled by Aspiro PharmaKetorolac Tromethamine	Aspiro Pharma	Particulate Matter	Nationwide
8 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
24 Aug 2022Drug	CLASS II	Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) recalledKetorolac Tromethamine	Nephron Sc	Manufacturing (CGMP) Deviations	Nationwide
3 Feb 2021Drug	CLASS I	Ketorolac Tromethamine Injection, USP, 30 mg per mL recalledKetorolac Tromethamine	Fresenius Kabi USA	Particulate Matter	Nationwide
6 Jan 2021Drug	CLASS II	Ketorolac Tromethamine Injection, USP, 60 mg per (30 mg per mL) recalledKetorolac Tromethamine	Fresenius Kabi USA	Particulate Matter	Nationwide
17 Jun 2020Drug	CLASS II	Ketorolac Tromethamine Injection, USP, 60 mg per (30 mg per mL) recalledKetorolac Tromethamine	Fresenius Kabi USA	Particulate Matter	Nationwide
17 Jun 2020Drug	CLASS I	Ketorolac Tromethamine Injection, USP, 30 mg per mL recalledKetorolac Tromethamine	Fresenius Kabi USA	Particulate Matter	Nationwide
22 Jan 2020Drug	CLASS I	Ketorolac Tromethamine Injection, USP 30 mg/mL recalledKetorolac Tromethamine	Hikma Pharmaceuticals USA	Particulate Matter	Nationwide
22 Jan 2020Drug	CLASS II	Ketorolac Tromethamine Injection, USP 60 mg/ (30 mg/mL) recalledKetorolac Tromethamine	Hikma Pharmaceuticals USA	Particulate Matter	Nationwide
15 May 2019Drug	CLASS II	Ketorolac Tromethamine Injection, USP, 60 mg recalledKetorolac Tromethamine	Sagent Pharmaceuticals	Sterility	Nationwide
22 Jul 2015Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 60 mg recalled by HospiraKetorolac Tromethamine	Hospira	Other	Nationwide
22 Jul 2015Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL) Fill recalledKetorolac Tromethamine	Hospira	Other	Nationwide
15 Apr 2015Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL) Fill recalledKetorolac Tromethamine	Hospira	Other	Nationwide
15 Apr 2015Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 60 mg recalled by HospiraKetorolac Tromethamine	Hospira	Other	Nationwide
25 Feb 2015Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 60 mg recalled by HospiraKetorolac Tromethamine	Hospira	Temperature Abuse	Nationwide
22 Oct 2014Drug	CLASS II	Ketorolac Tromethamine Injection, USP, 30 mg per mL, a) vial recalledKetorolac Tromethamine	Sagent Pharmaceuticals	Other	Nationwide
4 Sep 2013Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 30 mg vial recalled by HospiraKetorolac Tromethamine	Hospira	Sterility	IL

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.