CLASS I Drug recall · Reported 26 Aug 2020 · FDA Enforcement Report
Stimate (desmopressin acetate) Nasal Spray1.5 mg/mL glass recalled
Ferring Pharmaceuticals is recalling Stimate (desmopressin acetate) Nasal Spray1.5 mg/mL glass vial with spray cap, distributed nationwide in the US. The recall was initiated on 21 Jul 2020 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1506-2020
- FDA event ID
- 86066
- Recalling firm
- Ferring Pharmaceuticals, Parsippany, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Jul 2020
- FDA classified
- 17 Aug 2020
- Reported
- 26 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 21 Jul 2020 | Recall initiated by company | |
| 17 Aug 2020 | Classified by FDA | +27 days |
| 26 Aug 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
Where it was distributed
Nationwide within the United States.
Questions about this recall
Why was it recalled?
Superpotent Drug
Which lots are affected?
Lot # N14134C, exp. date 07 2020 N15378G, exp. date 09 2020 N17445N, exp. date 02 2020 P11326AA, exp. date 02 2021 P11326C, exp. date 02 2021 P13209L, exp. date 04 2021 P13212H, exp. date 06 2021 P13755A, exp. date 06 2021 P13756P, exp. date 08 2021 R11845A, exp. date 04 2022 R13271A, exp. date 04 2022 R13648A, exp. date 06 2022 R14101A, exp. date 07 2022 R14667A, exp. date 08 2022 R15953C, exp. date 09 2022
Where was it sold?
Nationwide within the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 86066| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Desmopressin Acetate Nasal Spray 10 mcg/ glass vial with spray cap recalled | Ferring Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS I | Ddavp Nasal Spray (desmopressin acetate) 10 mcg recalled | Ferring Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Ferring Pharmaceuticals
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Endometrin (progesterone) Vaginal Insert 100mg recalled | Ferring Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Zoma-Jet 5 Demonstration Kit recalled by Ferring Pharmaceuticals | Ferring Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Zoma-Jet 10 Demonstration Kit recalled by Ferring Pharmaceuticals | Ferring Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Menopur 75 IU, (menotropins for injection) recalledMenopur | Ferring Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Ddavp Nasal Spray (desmopressin acetate) 10 mcg recalled | Ferring Pharmaceuticals | Potency & Assay | Nationwide |