Ketorolac Injection (Fresenius Kabi) – Particulate Matter (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
Lot #: 6119229, 6119273, Exp 06/2020, 6119843, Exp 09/2020, 6121115, Exp 02/2021, 6121451, 6121452, 6121496, Exp 03/2021
Products Sold
Lot #: 6119229, 6119273, Exp 06/2020; 6119843, Exp 09/2020; 6121115, Exp 02/2021; 6121451, 6121452, 6121496, Exp 03/2021
Fresenius Kabi USA, LLC is recalling Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose V due to Presence of Particulate Matter - found in reserve sample vials at the firm.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particulate Matter - found in reserve sample vials at the firm.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026