FDA Drug Recalls

Recalls / Brands / Ketorolac Tromethamine

Ketorolac Tromethamine

18 FDA drug recalls involving brand “Ketorolac Tromethamine3 Class I.

DateClassProductFirm
2025-10-01Class IIKetorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use OnlAspiro Pharma Limited
2025-09-05Class IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., RichmoApotex Corp.
2025-05-28Class IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, OntarApotex Corp.
2022-08-10Class IIKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, NephNephron Sc Inc
2020-12-23Class IKetorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25Fresenius Kabi USA, LLC
2020-12-17Class IIKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx onFresenius Kabi USA, LLC
2020-04-20Class IIKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC Fresenius Kabi USA, LLC
2020-04-20Class IKetorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25Fresenius Kabi USA, LLC
2019-12-17Class IKetorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vialHikma Pharmaceuticals USA Inc.
2019-12-17Class IIKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043Hikma Pharmaceuticals USA Inc.
2019-04-30Class IIKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent PhSagent Pharmaceuticals Inc
2015-06-30Class IIKETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc.,Hospira Inc.
2015-06-30Class IIKETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Hospira Inc.
2015-01-23Class IIKETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc.,Hospira Inc.
2015-01-23Class IIKETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Hospira Inc.
2014-10-06Class IIKetorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per caHospira Inc.
2014-10-03Class IIKetorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-7Sagent Pharmaceuticals Inc
2013-08-12Class IIKetorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-379Hospira, Inc.