Prescription medicine
Neostigmine methylsulfate Brand names: Bloxiverz
Neostigmine methylsulfate (Bloxiverz) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 21 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the neostigmine methylsulfate FDA label on DailyMed (effective December 31, 2023, Exela Pharma Sciences, LLC); the NDA 204078 record on Drugs@FDA; every neostigmine methylsulfate label on DailyMed.
Highlights of the record
FDA label of December 31, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBLOXIVERZ, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
Forms and strengths
- 0.5 mg/ml
- 0.51 mg/ml
- 1 mg/ml
- 1.02 mg/ml
Injection; injection (solution).
On the market
- Earliest approval on file
- May 31, 2013 Bloxiverz, Exela Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first December 28, 2015; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 21 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 7 since 2015 2 Class I among all firms' recalls; latest November 9, 2023; 14 more by firms not listed as its makers
- FAERS reports
- 1,570 through July 30, 2026
What is neostigmine methylsulfate used for?
From the label: indications and usageBLOXIVERZ, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. BLOXIVERZ, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery ( 1 ).
FDA pharmacologic class: Cholinesterase Inhibitor.
Source: FDA drug label (Bloxiverz), Exela Pharma Sciences, LLC, effective December 31, 2023 (SPL set d2f55643-2b0d-4ef9-a9d8-b7138b314372), via openFDA; the full label on DailyMed
Is there a generic for neostigmine methylsulfate (Bloxiverz)?
The FDA approved the first generic neostigmine methylsulfate on December 28, 2015. 18 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists neostigmine methylsulfate from 21 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2013 earliest approval on file
- 2015 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is neostigmine methylsulfate in shortage?
No neostigmine methylsulfate presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated January 12, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Neostigmine Methylsulfate, Injection, .5 mg/1 mL (NDC 63323-413-10) | Fresenius Kabi USA, LLC | To Be Discontinued | January 12, 2026 |
Every neostigmine methylsulfate presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has neostigmine methylsulfate been recalled?
The FDA's Enforcement Report lists 21 recalls naming neostigmine methylsulfate since 2015: 2 Class I (the most serious), 19 Class II, 0 Class III; 0 still ongoing. 14 of them are by firms that FDA's NDC Directory does not list as a maker of neostigmine methylsulfate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 9, 2023 | Class II | SCA Pharmaceuticals, LLC | Lack of Assurance of Sterility |
| June 30, 2022 | Class II | Nephron Sterile Compounding Center LLC not a listed maker | Lack of Assurance of Sterility |
| May 18, 2022 | Class II | Nephron Sterile Compounding Center LLC not a listed maker | Lack of Assurance of Sterility |
| December 6, 2021 | Class II | Edge Pharma, LLC | Lack of Assurance of Sterility |
| December 17, 2020 | Class II | SCA Pharmaceuticals not a listed maker | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit |
| September 12, 2019 | Class II | KRS Global Biotechnology, Inc not a listed maker | Lack of Assurance of Sterility |
| June 18, 2019 | Class II | Premier Pharmacy Labs Inc not a listed maker | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process … |
| March 13, 2019 | Class II | Advanced Pharma Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the neostigmine methylsulfate label say about other medicines?
The neostigmine methylsulfate label names 8 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atropine | warnings and precautions | Atropine or glycopyrrolate should be administered prior to BLOXIVERZ to lessen risk of bradycardia. |
| Cefuroxime | drug interactions | There was no effect on neostigmine action on rocuronium reversal by cefuroxime, metronidazole, cefuroxime or metronidazole. |
| Glycopyrrolate | warnings and precautions | Atropine or glycopyrrolate should be administered prior to BLOXIVERZ to lessen risk of bradycardia. |
| Metronidazole | drug interactions | There was no effect on neostigmine action on rocuronium reversal by cefuroxime, metronidazole, cefuroxime or metronidazole. |
| Neomycin | drug interactions | Certain antibiotics, particularly neomycin, streptomycin and kanamycin have nondepolarizing neuromuscular blocking action, and therefore, neostigmine dose adjustments may be required to reverse neuromuscular block in patients who have been taking these drugs. |
| Rocuronium | drug interactions | There was no effect on neostigmine action on rocuronium reversal by cefuroxime, metronidazole, cefuroxime or metronidazole. |
| Streptomycin | drug interactions | Certain antibiotics, particularly neomycin, streptomycin and kanamycin have nondepolarizing neuromuscular blocking action, and therefore, neostigmine dose adjustments may be required to reverse neuromuscular block in patients who have been taking these drugs. |
| Succinylcholine | drug interactions | Use of neostigmine to reverse the effects of depolarizing muscle relaxants such as succinylcholine is not recommended, because it may prolong the phase-1 block. |
Source: FDA drug label (Bloxiverz), Exela Pharma Sciences, LLC, effective December 31, 2023 (SPL set d2f55643-2b0d-4ef9-a9d8-b7138b314372), via openFDA; the full label on DailyMed
What do FAERS reports show for neostigmine methylsulfate?
The FDA Adverse Event Reporting System holds 1,570 reports that list neostigmine methylsulfate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 164 are coded as a death and 688 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cholinesterase inhibitors
- the pharmacologic class, with prices and generics
- Neostigmine methylsulfate side effects
- the label's list beside FAERS reports
- Neostigmine methylsulfate shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other