Ketorolac Tromethamine recalls: 18 FDA reports
Recalls involving Ketorolac Tromethamine. What was wrong with each batch, and how the FDA graded the risk.
18Reports
3Class I
5Ongoing
2025-10-29Most recent
3 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Onl
D-0036-2026 · Class II · reported 2025-10-29 · Ongoing
- Why it was recalled
- Presence of Particulate Matter: Particulate matter identified as glass
- Product
- 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, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
- Where it went
- Nationwide within the United States
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmo
D-0677-2025 · Class II · reported 2025-10-08 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
- Product
- 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.
- Where it went
- Nationwide in the US
- How much
- 493,468 bottles
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontar
D-0494-2025 · Class II · reported 2025-07-02 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- 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
- Where it went
- US Nationwide.
- How much
- 87,840 bottles
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Neph
D-1354-2022 · Class II · reported 2022-08-24 · Terminated
- Why it was recalled
- cGMP Deviations: deviations leading to potential cross-contamination.
- Product
- 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
- Where it went
- USA Nationwide
- How much
- 5040 vials
Class I
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25
D-0245-2021 · Class I · reported 2021-02-03 · Terminated
- Why it was recalled
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Product
- 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, IL 60047.
- Where it went
- Nationwide USA and Puerto Rico
- How much
- 945,425 vials
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx on
D-0184-2021 · Class II · reported 2021-01-06 · Terminated
- Why it was recalled
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Product
- 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
- Where it went
- USA Nationwide and Puerto Rico
- How much
- 490,633 vials
Class I
Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25
D-1296-2020 · Class I · reported 2020-06-17 · Terminated
- Why it was recalled
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Product
- 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, IL 60047.
- Where it went
- USA Nationwide and Puerto Rico
- How much
- 5,314,400 vials
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC
D-1297-2020 · Class II · reported 2020-06-17 · Terminated
- Why it was recalled
- Presence of Particulate Matter - found in reserve sample vials at the firm.
- Product
- 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 only, Fresenius Kabi, Lake Zurich, IL 60047.
- Where it went
- USA Nationwide and Puerto Rico
- How much
- 3,497,575 vials
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043
D-0658-2020 · Class II · reported 2020-01-22 · Terminated
- Why it was recalled
- Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
- Product
- 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, NJ 07724 USA.
- Where it went
- Nationwide within the United States
- How much
- 25,817 shelf packs/25 vials per pack
Class I
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vial
D-0864-2020 · Class I · reported 2020-01-22 · Terminated
- Why it was recalled
- Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
- Product
- 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 07724 USA.
- Where it went
- Nationwide within the United States
- How much
- 101,710 25 vials/shelf-pack
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Ph
D-1274-2019 · Class II · reported 2019-05-15 · Terminated
- Why it was recalled
- 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.
- Product
- 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
- Where it went
- Nationwide USA and Puerto Rico
- How much
- 75,825 vials
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc.,
D-1241-2015 · Class II · reported 2015-07-22 · Ongoing
- Why it was recalled
- Crystallization; identified as calcium salt of Ketorolac
- Product
- 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 went
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- How much
- 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc.,
D-1242-2015 · Class II · reported 2015-07-22 · Ongoing
- Why it was recalled
- Crystallization; identified as calcium salt of Ketorolac
- Product
- 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
- Where it went
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- How much
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc.,
D-0483-2015 · Class II · reported 2015-04-15 · Terminated
- Why it was recalled
- Crystallization
- Product
- 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
- Where it went
- U.S. Nationwide and International: Guam and Singapore.
- How much
- HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc.,
D-0482-2015 · Class II · reported 2015-04-15 · Terminated
- Why it was recalled
- Crystallization
- Product
- 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 went
- U.S. Nationwide and International: Guam and Singapore.
- How much
- HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per ca
D-0388-2015 · Class II · reported 2015-02-25 · Terminated
- Why it was recalled
- Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
- Product
- 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.
- Where it went
- Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
- How much
- 100 vials
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-7
D-0027-2015 · Class II · reported 2014-10-22 · Terminated
- Why it was recalled
- 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.
- Product
- 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
- Where it went
- Nationwide and Puerto Rico
- How much
- 69,050 vials
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-379
D-926-2013 · Class II · reported 2013-09-04 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.
- Product
- Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
- Where it went
- Naitonwide
- How much
- 345,800 vials
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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