CLASS II ONGOING Drug recall · Reported 22 Apr 2026 · FDA Enforcement Report
Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled
Apotex is recalling Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses), distributed nationwide in the US. The recall was initiated on 8 Apr 2026 and the FDA has classified it as Class II.
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-0510-2026
- FDA event ID
- 98736
- Recalling firm
- Apotex, Weston, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Apr 2026
- FDA classified
- 1 May 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Nasal Sprays
Timeline
| 8 Apr 2026 | Recall initiated by company | |
| 22 Apr 2026 | Published in enforcement report | +14 days |
| 1 May 2026 | Classified by FDA | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Product as listed by the FDA
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Which lots are affected?
Lot #: VM4231, Exp 06/30/2027
Where was it sold?
U.S.A. Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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Other Desmopressin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desmopressin Acetate Tablet, 0.2 mg recalled by RemedyRepack | RemedyRepack | Potency & Assay | MI |
| Drug | CLASS II | Desmopressin Acetate Tablets 0.2mg recalled by Heritage PharmaceuticalsDesmopressin Acetate | Heritage Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Acetate Tablets, 0.2 mg recalled | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | TX |
| Drug | CLASS II | Desmopressin Acetate Injection USP, 4 mcg/mL Preserved Vial recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS I | Desmopressin Acetate Nasal Spray 10 mcg/ glass vial with spray cap recalled | Ferring Pharmaceuticals | Potency & Assay | Nationwide |