CLASS II ONGOING Drug recall · Reported 22 Jul 2015 · FDA Enforcement Report

Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL) Fill recalled

Hospira is recalling Ketorolac Tromethamine Inj., USP, 30 mg (30 mg/mL) Fill, Single-dose Vials, I.V/I.M. USE, distributed nationwide in the US. The recall was initiated on 30 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016

NDC0409-3793, 0409-3795, 0409-3796

Quantity recalled12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1241-2015
FDA event ID: 71681
Recalling firm: Hospira, Lake Forest, IL
Brand: Ketorolac Tromethamine
Manufacturer: Hospira, Inc.
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jun 2015
FDA classified: 15 Jul 2015
Reported: 22 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Pain Medication

Timeline

30 Jun 2015	Recall initiated by company
15 Jul 2015	Classified by FDA	+15 days
22 Jul 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Crystallization; identified as calcium salt of Ketorolac

Product as listed by the FDA

KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

Where it was distributed

Nationwide, Puerto Rico, Guam, Canada and Singapore

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Crystallization; identified as calcium salt of Ketorolac

Which lots are affected?

31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016

Where was it sold?

Nationwide, Puerto Rico, Guam, Canada and Singapore

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 71681

Reported	Class	Recall	Company	Reason	Where
22 Jul 2015	CLASS II	Ketorolac Tromethamine Inj., USP, 60 mg recalled by HospiraKetorolac Tromethamine	Hospira	Other	Nationwide

More recalls from Hospira

All 225

Reported	Class	Recall	Company	Reason	Where
31 May 2017Drug	CLASS I	Infant 25% Dextrose Injection recalled by HospiraDextrose	Hospira	Particulate Matter	Nationwide
18 Jan 2017Device	CLASS II	Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled	Hospira	Other	Nationwide
14 Dec 2016Drug	CLASS III	5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled	Hospira	Potency & Assay	PR
30 Nov 2016Drug	CLASS II	Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira	Hospira	Sterility	Nationwide
28 Sep 2016Device	CLASS II	LifeCare PCA 3, PCA recalled by Hospira	Hospira	Device Malfunction	Nationwide

Other Ketorolac Tromethamine recalls

All 24

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