Products Affected - Description

• • Diazepam injection, Pfizer, 5 mg/mL, 2 mL Carpuject syringe, 10 count, NDC 00409-1273-32

Reason for the Shortage

• • Dr. Reddy's has diazepam injection available.
  • Fresenius Kabi has diazepam injection available.
  • Hikma has diazepam injection available.
  • Natco has diazepam injection available.
  • Pfizer has diazepam injection on shortage due to manufacturing delays.

Available Products

• • Diazepam injection, Dr. Reddy's, 5 mg/mL, 2 mL syringe, 10 count, NDC 43598-0106-10
  • Diazepam injection, Fresenius Kabi, 5 mg/mL, 2 mL Simplist syringe, 24 count, NDC 76045-0204-20
  • Diazepam injection, Hikma, 5 mg/mL, 10 mL vial, 10 count, NDC 00641-6243-10
  • Diazepam injection, Hikma, 5 mg/mL, 2 mL syringe, 10 count, NDC 00641-6244-10
  • Diazepam injection, Natco, 5 mg/mL, 10 mL vial, 5 count, NDC 69339-0137-05
  • Diazepam injection, Natco, 5 mg/mL, 2 mL Luer Lock syringe, 10 count, NDC 69339-0137-34
  • Diazepam injection, Pfizer, 5 mg/mL, 10 mL vial, 10 count, NDC 00409-3213-12

• • Pfizer has diazepam 5 mg/mL 2 mL Carpuject syringes in limited supply with weekly releases.

• • FDA approved uses include:[1-2] 1. Alcohol withdrawal syndrome 2. Severe acute anxiety 3. Premedicated procedural anxiety 4. Seizure disorders including acute active seizures and status epilepticus 5. Muscle spasms and spasticity caused by upper motor neuron disorders
  • Off-labeled uses include:[1,3] 1. Hydroxychloroquine/Chloroquine toxicity. High dose diazepam injections have been found to reduce mortality in animals and lessen cardiotoxicity in humans and is the only benzodiazepine recommended with data. 2. Intoxication with sympathomimetics including cocaine and methamphetamine 3. Opioid withdrawal in the emergency setting 4. Organophosphate poisoning 5. Serotonin syndrome 6. Acute vertigo episode
  • Diazepam is on the Beers Criteria list, however benefits may outweigh the risk and can be used in older adult populations for seizure disorders, alcohol withdrawal, severe generalized anxiety disorder, and periprocedural anesthesia.[1,4]
  • In pediatric populations diazepam injections are used to treat:[1] 1. Acute seizures due to organophosphate poisoning 2. Status epilepticus 3. Spasticity and muscle spasms 4. Sedation, anxiolysis, and amnesia prior to procedures

• • Pfizer, in coordination with FDA, issued an Important Drug Warning Letter regarding a potential molding defect at the tip of the needle sheath. Visually examine Carpuject® units prior to administration and discard any unit showing a hole at the tip of the needle sheath as shown in pictures at https://www.pfizerhospitalus.com/sites/default/files/news_announcements/Issued%20Carpuject%20DHCPL%2027MAR2026.pdf.
  • Diazepam is on the AGS Beers Criteria list and is recommended to avoid use in ages 65 and older. A benefit vs. risk assessment should be considered with diazepam before use in the population.[4]

• • Oral, rectal, and intranasal formulations of diazepam exist and may be used depending on the indication and patient specific factors.[1]
  • For alcohol withdrawal syndrome chlordiazepoxide and lorazepam are also preferred benzodiazepines for treatment. Phenobarbital may also be used but is less preferred to benzodiazepines. The ASAM Clinical Practice Guideline on Alcohol Withdrawal Management can be found at https://www.asam.org/quality-care/clinical-guidelines/alcohol-withdrawal-management-guideline
  • Premedicated procedural anxiety pharmacologic alternative agents include midazolam, other benzodiazepines (oral, IV, and IM), gabapentinoids, beta-blockers, melatonin, and dexmedetomidine. Benzodiazepines are not recommended in elderly patients for this indication to avoid delirium and cognitive dysfunction. More information regarding perioperative anxiety can be found at https://pubmed.ncbi.nlm.nih.gov/40094863/
  • Rectal diazepam, IV lorazepam, and midazolam in buccal, intranasal, and IM formulations are suitable alternatives for injection diazepam in the treatment of status epilepticus in both pediatric and adult populations. IM midazolam is preferred in patients without IV access.[5-6]
  • In spasticity caused by upper motor neuron disorders other pharmacologic options include baclofen, tizanidine, dantrolene, and Botulinum Toxin. More information can be found at https://www.ncbi.nlm.nih.gov/books/NBK507869/
  • In severe acute anxiety situations and panic disorders fast acting benzodiazepines including alprazolam, lorazepam, and clonazepam as suitable alternatives.[7-8]
  • Diazepam injection is the preferred benzodiazepine for hydroxychloroquine toxicity, however other high dose benzodiazepines used for sedation and intubation may be beneficial if diazepam injections unavailable.[3]
  • In cocaine withdrawal nitroglycerin may also be used to treat coronary syndromes and chest pain.[9-10]
  • Other benzodiazepines can be considered to treat methamphetamine intoxication causing severe agitation, aggressiveness, psychosis, or epileptic seizures. More information regarding methamphetamine related toxicity can be found at https://pubmed.ncbi.nlm.nih.gov/28297728/
  • Other benzodiazepines (notably lorazepam and midazolam) and alpha-2 adrenergic agonists can be used to help with agitation, hypertension, tachycardia, anxiety, restlessness, dysphoria, insomnia, and muscle cramping associated with opioid withdrawal.[1,11]
  • In the case of organophosphate poisoning, midazolam is a suitable alternative to diazepam for seizures caused by cholinergic toxidrome causing nerve agents. More information regarding this recommendation can be found in this study https://www.sciencedirect.com/science/article/pii/S002839082400340X
  • Diazepam has been studied the most for mild symptoms of agitation, fever, hypertension, and tachycardia in serotonin syndrome. Other benzodiazepines or routes of administration of diazepam may be beneficial to substitute diazepam injection if unavailable. More information about serotonin syndrome can be found at https://pmc.ncbi.nlm.nih.gov/articles/PMC3865832/
  • For acute vertigo attacks in patients with Ménière disease lorazepam and clonazepam are suitable alternatives to suppress vertigo symptoms. More information on clinical practice guidelines for Ménière's Disease can be found at https://pubmed-ncbi-nlm-nih-gov.ezproxy.lib.utah.edu/32267799/
  • Benign paroxysmal positional vertigo guidelines now do not recommend treatment with benzodiazepines. Exceptions to this may include patients with severe symptoms refusing other treatment and patients who require prophylaxis for CRP. Updated BPPV guidelines can be found at https://pubmed-ncbi-nlm-nih-gov.ezproxy.lib.utah.edu/28248609/

• 1. Diazepam. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed; Accessed June 3, 2026.¿¿
  2. Diazepam injection, solution. Package insert. Hospira. Retrieved from dailymed.nlm.nih.gov; 2024
  3. Hydroxychloroquine Sulfate. DynaMed [database online]. Ipswich (MA): EBSCO Information Services.¿http://www.dynamed.com. Accessed June 4, 2026.
  4. By the 2023 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-2081.doi:10.1111/jgs.18372
  5. McMullan J, Sasson C, Pancioli A, Silbergleit R. Midazolam versus diazepam for the treatment of status epilepticus in children and young adults: a meta-analysis.¿Acad Emerg Med. 2010;17(6):575-582. doi:10.1111/j.1553-2712.2010.00751.x
  6. Midazolam. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed; Accessed June 4, 2026.¿¿
  7. Raju NN, Naga Pavan Kumar KSVR, Nihal G. Clinical Practice Guidelines for Assessment and Management of Anxiety and Panic Disorders in Emergency Setting.¿Indian J Psychiatry. 2023;65(2):181-185. doi:10.4103/indianjpsychiatry.indianjpsychiatry_489_22
  8. American Psychiatric Association. Practice Guideline for the Treatment of Patients With Panic Disorder. 2nd ed. American Psychiatric Association; 2009. Accessed June 5, 2026. Available at: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/panicdisorder.pdf
  9. Lavonas EJ, Akpunonu PD, Arens AM, et al. 2023 American Heart Association Focused Update on the Management of Patients With Cardiac Arrest or Life-Threatening Toxicity Due to Poisoning: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.¿Circulation. 2023;148(16):e149-e184. doi:10.1161/CIR.0000000000001161
  10. Baumann BM, Perrone J, Hornig SE, Shofer FS, Hollander JE. Randomized, double-blind, placebo-controlled trial of diazepam, nitroglycerin, or both for treatment of patients with potential cocaine-associated acute coronary syndromes.¿Acad Emerg Med. 2000;7(8):878-885. doi:10.1111/j.1553-2712.2000.tb02065.x
  11. Opioid withdrawal in adults in the emergency setting. UpToDate online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed; Accessed June 5, 2026.¿¿