Desmopressin Acetate Spray
FDA Recall NDC 60505-0815
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Desmopressin Acetate (NDC 60505-0815). A significant event, classified as Class II, was initiated on Apr 08, 2026 by Apotex Corp.. The reported reason for this action was: "Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Apr 08, 2026
Apr 22, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98736
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# : VM4231, Exp 06/30/2027
Affected Packages Involved in this Recall
60505-0815-0Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
