FDA Recall D-0510-2026

Apotex Corp. · Weston, FL

Class II Ongoing 36 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: VM4231, Exp 06/30/2027

Quantity: N/A

Reason for recall

Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.

Recall record

Recall number: D-0510-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: U.S.A. Nationwide
Recall initiated: 2026-04-08
Classified by FDA Center: 2026-05-01
FDA published: 2026-04-22
Recalling firm: Apotex Corp.
Firm location: Weston, FL

Drug identification

Brand name(s): DESMOPRESSIN ACETATE
Generic name(s): DESMOPRESSIN ACETATE
Manufacturer(s): Apotex Corp.
NDC(s): 60505-0815
Route(s): NASAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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