Ketorolac tromethamine

What Ketorolac tromethamine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. …

— FDA label: Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, film coated, oral), Ketorolac Tromethamine, Remedyrepack Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 136 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Read it on the full label →

107 of 136 FDA labels for this medicine have a boxed warning.

Ketorolac tromethamine boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following intravenous or intramuscular dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine should not exceed 5 days.

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Ketorolac tromethamine is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events. GASTROINTESTINAL RISK Ketorolac tromethamine, including ketorolac tromethamine tablets can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS). CARDIOVASCULAR THOMBOTIC EVENTS Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS). Ketorolac tromethamine tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS). RENAL RISK Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see WARNINGS). RISK OF BLEEDING Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS). Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery. RISK DURING LABOR AND DELIVERY The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions. CONCOMITANT USE WITH NSAIDs Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects. SPECIAL POPULATIONS Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (see DOSAGE AND ADMINISTRATION) and for patients with moderately elevated serum creatinine (see WARNINGS).

— FDA label: Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026. Read the full label on DailyMed →

Ketorolac tromethamine side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see Boxed WARNING, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION).

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These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.

— FDA label: Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026. This is part of the section. Read the full label on DailyMed →

Ketorolac tromethamine drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac tromethamine induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs. Warfarin, Digoxin, Salicylate, and Heparin The in vitro binding of warfarin to plasma proteins is only slightly reduced by ketorolac tromethamine (99.5% control vs 99.3%) when ketorolac plasma concentrations reach 5 mcg/mL to 10 mcg/mL.

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Ketorolac does not alter digoxin protein binding. In vitro studies indicate that, at therapeutic concentrations of salicylate (300 mcg/mL), the binding of ketorolac was reduced from approximately 99.2% to 97.5%, representing a potential twofold increase in unbound ketorolac plasma levels. Therapeutic concentrations of digoxin, warfarin, ibuprofen, naproxen, piroxicam, acetaminophen, phenytoin and tolbutamide did not alter ketorolac tromethamine protein binding. In a study involving 12 adult volunteers, ketorolac tromethamine tablets were co-administered with a single dose of 25 mg warfarin, causing no significant changes in pharmacokinetics or pharmacodynamics of warfarin. In another study, ketorolac tromethamine dosed intravenous or intramuscular was given with two doses of 5,000 U of heparin to 11 healthy volunteers, resulting in a mean template bleeding time of 6.4 minutes (3.2 min to 11.4 min) compared to a mean of 6 minutes (3.4 min to 7.5 min) for heparin alone and 5.1 minutes (3.5 min to 8.5 min) for placebo. Although these results do not indicate a significant interaction between ketorolac tromethamine and warfarin or heparin, the administration of ketorolac tromethamine to patients taking anticoagulants should be done extremely cautiously, and patients should be closely monitored (see WARNINGS and PRECAUTIONS, Hematologic Effect). The effects of warfarin and NSAIDs, in general, on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than the users of either drug alone. Aspirin When ketorolac tromethamine is administered with aspirin, its protein binding is reduced, although the clearance of free ketorolac tromethamine is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ketorolac tromethamine and aspirin is not generally recommended because of the potential of increased adverse effects. Diuretics Clinical studies, as well as post marketing observations, have shown that ketorolac tromethamine can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as to assure diuretic efficacy. Probenecid Concomitant administration of ketorolac tromethamine tablets and probenecid resulted in decreased clearance and volume of distribution of ketorolac and significant increases in ketorolac plasma levels (total AUC increased approximately threefold from 5.4 mcg/h/mL to 17.8 mcg/h/mL) and terminal half-life increased approximately twofold from 6.6 hours to 15.1 hours.

— FDA label: Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026. This is part of the section. Read the full label on DailyMed →

Ketorolac tromethamine dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.

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In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to intravenous or intramuscular dosing of ketorolac tromethamine. Transition from intravenous or intramuscular dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 hours to 6 hours prn not > 40 mg/day Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 hours to 6 hours prn not > 40 mg/day Note: Oral formulation should not be given as an initial dose Use minimum effective dose for the individual patient Do not shorten dosing interval of 4 hours to 6 hours Total duration of treatment in adult patients: the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group: Table 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (Following Intravenous or Intramuscular dosing of ketorolac tromethamine) Age < 17 years Oral not approved Adult Age 17 years to 64 years 20 mg once, then 10 mg q4 hours to 6 hours prn not > 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg 10 mg once, then 10 mg q4 hours to 6 hours prn not > 40 mg/day

— FDA label: Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026. Read the full label on DailyMed →

Ketorolac tromethamine in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Use of NSAIDs, including ketorolac tromethamine tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

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Because of these risks, limit dose and duration of ketorolac tromethamine tablets use between about 20 weeks and 30 weeks of gestation, and avoid ketorolac tromethamine tablets use at about 30 weeks of gestation and later in pregnancy (see WARNINGS; Fetal Toxicity). Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including ketorolac tromethamine tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. Animal reproduction studies have been performed during organogenesis using daily oral doses of ketorolac tromethamine at 3.6 mg/kg (0.37 times the human AUC) in rabbits and at 10 mg/kg (1 times the human AUC) in rats. Results of these studies did not reveal evidence of teratogenicity to the fetus. However, animal reproduction studies are not always predictive of human response. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ketorolac tromethamine, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including ketorolac tromethamine tablets, can cause premature closure of the fetal ductus arteriosus (see WARNINGS; Fetal Toxicity). Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible.

— FDA label: Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026. This is part of the section. Read the full label on DailyMed →

Ketorolac tromethamine and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

Limited data from one published study involving 10 breastfeeding women 2 days to 6 days postpartum showed low levels of ketorolac in breast milk. Levels were undetectable (less than 5 ng/mL) in 4 of the patients. After a single administration of 10 mg of ketorolac tromethamine tablets, the maximum milk concentration observed was 7.3 ng/mL, and the maximum milk-to-plasma ratio was 0.037.

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After 1 day of dosing (10 mg every 6 hours), the maximum milk concentration was 7.9 ng/mL, and the maximum milk-to-plasma ratio was 0.025. Assuming a daily intake of 400 mL to 1,000 mL of human milk per day and a maternal body weight of 60 kg, the calculated maximum daily infant exposure was 0.00263 mg/kg/day, which is 0.4% of the maternal weight-adjusted dose. Exercise caution when ketorolac is administered to a nursing woman. Available information has not shown any specific adverse events in nursing infants; however, instruct patients to contact their infant's health care provider if they note any adverse events.

— FDA label: Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026. Read the full label on DailyMed →

When Ketorolac tromethamine should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

(See also Boxed WARNING). Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. Ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.

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Ketorolac tromethamine should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma). Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery. Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). Ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see WARNINGS for correction of volume depletion). Ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS). Ketorolac tromethamine is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events. The concomitant use of ketorolac tromethamine and probenecid is contraindicated. The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.

— FDA label: Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026. Read the full label on DailyMed →

Ketorolac tromethamine overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Symptoms and Signs Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

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Treatment Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 g to 100 g in adults, 1 g/kg to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large oral overdose (5 times to 10 times the usual dose). Forced diuresis, alkalization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding. Single overdoses of ketorolac tromethamine have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing.

— FDA label: Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines that contain Ketorolac tromethamine

• Phenylephrine and ketorolacOmidria · 2 products

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• A-S Medication Solutions12 products
• Fresenius Kabi USA, LLC10 products
• NuCare Pharmaceuticals, Inc.8 products
• Remedyrepack Inc.7 products
• Sportpharm LLC7 products
• Bryant Ranch Prepack6 products
• Medical Purchasing Solutions, LLC6 products
• Sun Pharmaceutical Industries, Inc.6 products
• Onesource Specialty Pharma Limited6 products
• Caplin Steriles Limited6 products
• Proficient Rx LP6 products
• Redpharm Drug6 products
• Cardinal Health 107, LLC5 products
• Baxter Healthcare Corporation5 products
• Camber Pharmaceuticals, Inc.4 products
• Civica, Inc.4 products
• Preferred Pharmaceuticals Inc.4 products
• SOLA Pharmaceuticals, LLC4 products
• Anthea Pharma Private Limited3 products
• Allergan, Inc.3 products
• Eugia US LLC3 products
• Alembic Pharmaceuticals Inc.3 products
• Glenmark Pharmaceuticals Inc., USA3 products
• Fosun Pharma USA Inc.3 products
• Direct_Rx3 products
• Hikma Pharmaceuticals USA Inc.3 products
• Hospira, Inc.3 products
• Asclemed USA, Inc.3 products
• Gland Pharma Limited3 products
• Henry Schein, Inc.3 products
• HF Acquisition Co LLC, DBA HealthFirst3 products
• PD-Rx Pharmaceuticals, Inc.2 products
• Advanced Rx Pharmacy of Tennessee, LLC2 products
• ProPharma Distribution2 products
• Sagent Pharmaceuticals2 products
• Injecta Medcial LLC2 products
• Aurobindo Pharma Limited2 products
• Northwind Health Company, LLC2 products
• Leading Pharma, LLC2 products
• Major Pharmaceuticals1 product
• Micro Labs Limited1 product
• Amici Pharma, Inc.1 product
• Atnahs Pharma US Limited1 product
• Pacific Pharma, Inc.1 product
• Chartwell RX, LLC1 product
• Zydus Pharmaceuticals USA Inc.1 product
• Zydus Lifesciences Limited1 product
• Zyla Life Sciences US LLC1 product
• Advanced Rx of Tennessee, LLC1 product
• Ajanta Pharma USA Inc.1 product
• Apotex Corp.1 product
• Bionpharma Inc.1 product
• Golden State Medical Supply, Inc.1 product
• Mylan Pharmaceuticals Inc.1 product
• Dr. Reddy's Laboratories Inc.1 product
• American Health Packaging1 product
• St. Mary's Medical Park Pharmacy1 product
• Sandoz Inc1 product
• Nephron Pharmaceuticals Corporation1 product
• Amerisyn LLC1 product
• Teva Pharmaceuticals USA, Inc.1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (32)

• ANDA074754Teva · May 16, 1997
• ANDA074761Mylan · May 16, 1997
• ANDA074802Hospira · June 5, 1997
• ANDA075784Fresenius Kabi USA · January 11, 2002
• ANDA075772Hikma · July 21, 2004
• ANDA078299Onesource Specialty · July 16, 2007
• ANDA078737Sun Pharm · October 6, 2008
• ANDA076109Apotex · November 5, 2009
• ANDA076583Sandoz · November 5, 2009
• ANDA078434Chartwell Rx · November 5, 2009
• ANDA090017Sun Pharm · November 5, 2009
• ANDA201155Onesource Specialty · August 4, 2014
• ANDA203242Fresenius Kabi USA · October 7, 2015
• ANDA204216Gland · November 1, 2016
• ANDA209900Baxter Hlthcare Corp · September 15, 2017
• ANDA210616Chartwell Rx · August 16, 2018
• ANDA205191Eugia Pharma · November 15, 2018
• ANDA203410Micro Labs Ltd India · April 5, 2019
• ANDA211445Nephron · August 20, 2020
• ANDA212939Eugia Pharma · October 20, 2020
• ANDA205190Eugia Pharma · December 3, 2020
• ANDA215788Pharmazone · March 23, 2022
• ANDA216651Hetero Labs Ltd III · August 25, 2022
• ANDA216407Atnahs Pharma Us · October 21, 2022
• ANDA217038Zydus Lifesciences · October 21, 2022
• ANDA214456Alembic · November 2, 2022
• ANDA215745Leading · February 23, 2023
• ANDA216759Bionpharma · February 23, 2023
• ANDA217789Caplin · May 10, 2023
• ANDA217166Aspiro · June 20, 2023
• ANDA218204Caplin · March 26, 2024
• ANDA221041Anthea Pharma · September 25, 2026

Shortage status

Current shortage · updated October 21, 2026 · first posted March 26, 2018

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. October 1, 2025 · Class II · Ongoing · D-0036-2026

   Presence of Particulate Matter: Particulate matter identified as glass

   Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Tela — Aspiro Pharma Limited

2. September 5, 2025 · Class II · Ongoing · D-0677-2025

   Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

   Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1. — Apotex Corp.

3. May 28, 2025 · Class II · Ongoing · D-0494-2025

   Lack of Assurance of Sterility

   Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2 — Apotex Corp.

4. August 10, 2022 · Class II · Terminated · D-1354-2022

   cGMP Deviations: deviations leading to potential cross-contamination.

   Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01 — Nephron Sc Inc

5. December 23, 2020 · Class I · Terminated · D-0245-2021

   Presence of Particulate Matter - found in reserve sample vials at the firm.

   Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, — Fresenius Kabi USA, LLC

6. December 17, 2020 · Class II · Terminated · D-0184-2021

   Presence of Particulate Matter - found in reserve sample vials at the firm.

   Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02 — Fresenius Kabi USA, LLC

7. April 20, 2020 · Class I · Terminated · D-1296-2020

   Presence of Particulate Matter - found in reserve sample vials at the firm.

   Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, — Fresenius Kabi USA, LLC

8. April 20, 2020 · Class II · Terminated · D-1297-2020

   Presence of Particulate Matter - found in reserve sample vials at the firm.

   Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx on — Fresenius Kabi USA, LLC

9. December 17, 2019 · Class II · Terminated · D-0658-2020

   Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

   Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, — Hikma Pharmaceuticals USA Inc.

10. December 17, 2019 · Class I · Terminated · D-0864-2020

    Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)

    Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 0772 — Hikma Pharmaceuticals USA Inc.

11. April 30, 2019 · Class II · Terminated · D-1274-2019

    Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

    Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02 — Sagent Pharmaceuticals Inc

12. June 30, 2015 · Class II · Ongoing · D-1242-2015

    Crystallization; identified as calcium salt of Ketorolac

    KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49 — Hospira Inc.

13. June 30, 2015 · Class II · Ongoing · D-1241-2015

    Crystallization; identified as calcium salt of Ketorolac

    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 — Hospira Inc.

14. January 23, 2015 · Class II · Terminated · D-0482-2015

    Crystallization

    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 — Hospira Inc.

15. January 23, 2015 · Class II · Terminated · D-0483-2015

    Crystallization

    KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49 — Hospira Inc.

16. October 6, 2014 · Class II · Terminated · D-0388-2015

    Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

    Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01. — Hospira Inc.

17. October 3, 2014 · Class II · Terminated · D-0027-2015

    Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.

    Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 — Sagent Pharmaceuticals Inc

18. August 12, 2013 · Class II · Terminated · D-926-2013

    Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.

    Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01 — Hospira, Inc.

Official identifiers

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Ketorolac Tromethamine, Remedyrepack Inc., effective August 28, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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