Fresenius Kabi Recalls Ketorolac Tromethamine Injection Due to Particulate Matter
Fresenius Kabi is recalling 490,633 vials of Ketorolac Tromethamine Injection because particulate matter was found in reserve samples.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential significant injury or property damage risks associated with particulate matter in injectable drugs.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 490,633 vials of Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL). The product is packaged in 2 mL Single Dose Vials and is available by prescription only. The specific batch involved is # 6121125 with an expiration date of 02/2021.
The recall was initiated because particulate matter was found in reserve sample vials at the firm. The FDA has classified this as a Class II recall. The product was distributed nationwide in the United States and in Puerto Rico.
Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions. Consumers should not use the product if they have any concerns regarding its quality or safety.
The recalled product
- Product
- KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
- Brand
- KETOROLAC TROMETHAMINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 490,633
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 (2)
- Batch # 6121125
- Exp 02/2021
UPCs (4)
- 0363323162115
- 0363323161002
- 0363323162009
- 0363323162030
Distribution
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
- CriticalFresenius Kabi Recalls Fluorouracil Injection Due to Glass Particulates
FDA (Drugs) · 2019-07-24
- SevereFresenius Kabi Recalls Benztropine Mesylate Injection Due to Glass Particulates
FDA (Drugs) · 2013-07-17