Fresenius Kabi Recalls Ketorolac Tromethamine Injection Due to Particulate Matter
Fresenius Kabi is recalling specific lots of Ketorolac Tromethamine Injection because particulate matter was found in reserve sample vials.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 5,314,400 vials of Ketorolac Tromethamine Injection, USP, 30 mg per mL. The affected product is packaged in 1 mL Single Dose Vials and is intended for intramuscular or intravenous use. The recall covers distribution across the USA Nationwide and Puerto Rico.
The recall was initiated because particulate matter was found in reserve sample vials at the firm. The specific lots affected are 6118737, 6118902, 6119052, 6119752, 6122349, and 6122538, with expiration dates ranging from April 2020 to September 2021.
Healthcare providers and patients should stop using the affected lots of this medication. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 5,314,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot #: 6118737
- 6118902
- Exp 04/2020
- 6119052
- Exp 05/2020
- 6119752
- Exp 08/2020
- 6122349
- Exp 07/2021
- 6122538
- Exp 09/2021
UPCs (4)
- 0363323162115
- 0363323161002
- 0363323162009
- 0363323162030
Distribution
Part of a larger recall action
This product is one of 2 recalled by Fresenius Kabi USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · KETOROLAC TROMETHAMINE
- HighKetorolac injection vials recalled after glass particulate found in product
FDA (Drugs) · 2025-10-29
- HighKetorolac ophthalmic solution recalled over sterility assurance and bottle sealing concerns
FDA (Drugs) · 2025-10-08
- SevereKetorolac Tromethamine Ophthalmic Solution Recalled for Sterility Risk
FDA (Drugs) · 2025-07-02
- HighInjectable ketorolac tromethamine recalled nationwide for potential cross-contamination
FDA (Drugs) · 2022-08-24
- SevereFresenius Kabi Recalls Ketorolac Tromethamine Injection Due to Particulate Matter
FDA (Drugs) · 2021-02-03
Same manufacturer · Fresenius Kabi USA, LLC
See all →- SevereFresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
- CriticalFresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
- HighNaropin Injection Recall Over Particulate Matter Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- HighXylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- SevereFresenius Kabi Recalls Ketorolac Tromethamine Injection Due to Particulate Matter
FDA (Drugs) · 2021-02-03
- CriticalHikma Recalls Ketorolac Tromethamine Injection Due to Particulate Matter
FDA (Drugs) · 2020-01-22
- HighKetorolac injection vials recalled after glass particulate found in product
FDA (Drugs) · 2025-10-29
- ModerateAmphastar Recalls Ketorolac Injection Due to Crystallization
FDA (Drugs) · 2017-09-06
- CriticalRemedyRepack Recalls Ketorolac Tromethamine Injections Due to Particulate Matter
FDA (Drugs) · 2020-02-19
- CriticalFresenius Kabi Recalls Fluorouracil Injection Due to Glass Particulates
FDA (Drugs) · 2019-07-24