Ketorolac Tromethamine recalls

The FDA has published 24 recalls involving Ketorolac Tromethamine since 2012. The latest was reported on 29 Oct 2025. Most were for particulate matter. Hospira 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 recalls24since 2012

Last 12 months1reported

Class I313% of total

Ongoing7latest 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 13%Class II 21 88%Class III 0 0%

Why ketorolac tromethamine is recalled

Companies

By year

2025313%
202328%
202214%
202128%
2020417%
201914%
201714%
2015625%
201414%
201328%

Ongoing ketorolac tromethamine recalls

7 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
7 Jun 2023Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile recalled	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide
22 Jul 2015Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 60 mg recalled by HospiraKetorolac Tromethamine	Hospira	Other	Nationwide

All ketorolac tromethamine recalls, newest first

24 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
7 Jun 2023Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile recalled	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	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
6 Sep 2017Drug	CLASS II	Ketorolac Tromethamine Injection, USP 30 mg/mL recalled	Amphastar Pharmaceuticals	Particulate Matter	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
4 Mar 2015Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled	Sun Pharma Global Fze	Particulate Matter	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
18 Sep 2013Drug	CLASS II	Ketorolac Tromethamine 60 MG/ML Injectable recalled	Beacon Hill Medical Pharmacy, P.C	Sterility	Nationwide
4 Sep 2013Drug	CLASS II	Ketorolac Tromethamine Inj., USP, 30 mg vial recalled by HospiraKetorolac Tromethamine	Hospira	Sterility	IL
22 Aug 2012Drug	CLASS II	Ketorolac Tromethamine 30mg/ML Injectable recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Ketorolac Tromethamine?

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.

Alert me about Ketorolac Tromethamine

One email the day a new recall is posted for Ketorolac Tromethamine. Unsubscribe any time.

At a glance

Latest recall: 29 Oct 2025
First on record: 22 Aug 2012
Class I share: 13%
Ongoing: 7

Drug classes

Injectable & IV Drugs 4,627Pain Medication 1,518Creams, Ointments & Gels 930Blood Pressure Medication 837Compounded Drugs 721Eye Drops 600Hormones & Birth Control 495Antibiotics 492Allergy Medication 348Stomach & Acid Reflux Medication 313Cold & Cough Medicine 312Diabetes Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.