Ketorolac Tromethamine: 14 recalls on record

Recalled by 1 agency: FDA (14).

First recall on record: September 4, 2013. Most recent: October 29, 2025.

Risk classification: Class I: 2 · Class II: 12

Most recent recalls

DateAgencyProduct
October 29, 2025FDAKetorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For …D-0036-2026
October 8, 2025FDAKetorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by…D-0677-2025
July 2, 2025FDAKetorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex…D-0494-2025
August 24, 2022FDAKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose…D-1354-2022
January 6, 2021FDAKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Si…D-0184-2021
June 17, 2020FDAKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Si…D-1297-2020
June 17, 2020FDAKetorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (…D-1296-2020
January 22, 2020FDAKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose…D-0658-2020
January 22, 2020FDAKetorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0…D-0864-2020
May 15, 2019FDAKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx onl…D-1274-2019
July 22, 2015FDAKETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M…D-1241-2015
July 22, 2015FDAKETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M.…D-1242-2015
October 22, 2014FDAKetorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2…D-0027-2015
September 4, 2013FDAKetorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 600…D-926-2013

Questions about this brand

How many recalls does Ketorolac Tromethamine have?
Recalert has 14 U.S. recalls on record for Ketorolac Tromethamine, published between September 4, 2013 and October 29, 2025.
What was the most recent Ketorolac Tromethamine recall?
FDA recall D-0036-2026, published October 29, 2025: 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…
Which agencies have recalled Ketorolac Tromethamine products?
Ketorolac Tromethamine products appear in recalls from: FDA (14).

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