April 2026 FDA Recall Desmopressin Acetate by Apotex Corp.
D-0510-2026 - Defective container
This Class II drug recall was voluntarily initiated by Apotex Corp. on April 8, 2026 for the product Desmopressin Acetate. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0510-2026
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
04-08-2026
04-22-2026
N/A
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
