STIMATE® (desmopressin acetate) Nasal Spray 1.5 milligram/milliliter

On August 5, 2020, CSL Behring, the manufacturer of STIMATE® (desmopressin acetate) Nasal Spray, issued a voluntary recall of all lots on the market.

October 23, 2020  

This recall was issued due to superpotency or amounts of desmopressin higher than specified, which may represent a potential safety risk.

What do you need to do?

  • Do not stop taking your medication without speaking with your doctor. The U.S. Food and Drug Administration (FDA) recommends that patients continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
  • Please call your doctor right away to obtain a new prescription for another appropriate medication. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption

To get more information or to report any adverse events or quality problems experienced with the use of this product, you can contact CSL Behring directly, or you can report to the FDA's MedWatch Program.

  • Manufacturer Information:

CSL Behring:
Phone: 800.504.5434
Email: MedinfoNA@cslbehring.com

  • To report an adverse event to the FDA Med Watch Program:

Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda

Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/forms-reporting-fda mail or submit by fax to 800.FDA.0178

Affected NDCs:

Lot

Exp Date

NDC #

Stimate® Nasal Spray 1.5 mg/mL, 2.5 mL

N14134C

07/2020

0053-6871-00

N15378G

09/2020

0053-6871-00

N17445N

12/2020

0053-6871-00

P11326AA

02/2021

0053-6871-00

P11326C

02/2021

0053-6871-00

P13209L

04/2021

0053-6871-00

P13212H

06/2021

0053-6871-00

P13755A

06/2021

0053-6871-00

P13756P

08/2021

0053-6871-00

R11845A

04/2022

0053-6871-00

R13271A

04/2022

0053-6871-00

R13648A

06/2022

0053-6871-00

R14101A

07/2022

0053-6871-00

R14667A

08/2022

0053-6871-00

R15953C

09/2022

0053-6871-00