FDA Recall D-0245-2026

Novo Nordisk Inc. · Plainsboro, NJ

Class II Ongoing 146 days on record

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

Product

Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14

Lot / code: Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027

Quantity: N/A

Reason for recall

Presence of Particulate Matter: Hair was found in a prefilled syringe

Recall record

Recall number: D-0245-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States.
Recall initiated: 2025-12-19
Classified by FDA Center: 2025-12-31
FDA published: 2026-01-07
Recalling firm: Novo Nordisk Inc.
Firm location: Plainsboro, NJ

Drug identification

Brand name(s): WEGOVY
Generic name(s): SEMAGLUTIDE
Manufacturer(s): Novo Nordisk
NDC(s): 0169-4404, 0169-4525, 0169-4505, 0169-4501, 0169-4517, 0169-4524, 0169-4415, 0169-4409, 0169-4425, 0169-4572
Route(s): ORAL

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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