Baxter Recalls Brevibloc Injection Due to Particulate Matter
Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection due to complaints of discolored solution and subvisible iron oxide particles.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Baxter Healthcare Corp. is recalling 20,810 containers of Brevibloc (esmolol hydrochloride) Premixed Injection. The product is an intravenous prescription drug packaged in 250 mL Single Use IntraVia containers. The recall covers Lot # C926923 with an expiration date of 01/16.
The recall was initiated due to complaints identifying a discolored solution containing subvisible particles of iron oxide that are agglomerating. This particulate matter was found in the product.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled product and contact Baxter Healthcare or their local FDA office for further instructions.
The recalled product
- Product
- BREVIBLOC (ESMOLOL HYDROCHLORIDE)
- Brand
- BREVIBLOC
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Prescription Injection
- Affected units
- 20,810
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)
- Lot #: C926923
- Exp 01/16
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · BREVIBLOC
- ModerateBaxter Recalls Brevibloc Injection Due to Yellow Discoloration
FDA (Drugs) · 2016-05-18
Same manufacturer · Baxter Healthcare Corp.
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- CriticalAmerican Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26