Inicio/Ver Todos los Retiros/FDA-D-0245-2026
FDA DrugsClass II

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

Publicado: 7 de enero de 2026ID de Retiro: D-0245-2026Categoría: Medicamentos y FármacosPaís: Estados Unidos
US
PharmaceuticalFDA DrugsUSUS

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

Recalling Firm: Novo Nordisk Inc.

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Traducir AvisoTranslate notice text, hazard warnings, and descriptions into any supported language.

Motivo del Retiro / Peligro

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

Descripción del Producto e Identificación

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

Additional Source Details

FieldValue
CityPlainsboro
StateNJ
Openfda › Nui › 1N0000178480
Openfda › Nui › 2M0160181
Openfda › Nui › 3N0000020058
Openfda › Unii53AXN4NNHX
Openfda › RouteSUBCUTANEOUS
Openfda › Spl idf38985f6-b16a-426b-9c0d-6d4815acebfe
Openfda › Brand nameWEGOVY
Openfda › Spl set idee06186f-2aa3-4990-a760-757579d8f77b
Openfda › Package ndc › 10169-4525-01
Openfda › Package ndc › 20169-4525-14
Openfda › Package ndc › 30169-4525-90
Openfda › Package ndc › 40169-4525-94
Openfda › Package ndc › 50169-4505-01
Openfda › Package ndc › 60169-4505-14
Openfda › Package ndc › 70169-4501-01
Openfda › Package ndc › 80169-4501-14
Openfda › Package ndc › 90169-4517-01
Openfda › Package ndc › 100169-4517-14
Openfda › Package ndc › 110169-4524-01
Openfda › Package ndc › 120169-4524-14
Openfda › Package ndc › 130169-4572-01
Openfda › Package ndc › 140169-4572-14
Openfda › Package ndc › 150169-1602-01
Openfda › Package ndc › 160169-1602-14
Openfda › Package ndc › 170169-1602-90
Openfda › Package ndc › 180169-1602-94
Openfda › Package ndc › 190169-1605-01
Openfda › Package ndc › 200169-1605-14
Openfda › Package ndc › 210169-1610-01
Openfda › Package ndc › 220169-1610-14
Openfda › Package ndc › 230169-1617-01
Openfda › Package ndc › 240169-1617-14
Openfda › Package ndc › 250169-1624-01
Openfda › Package ndc › 260169-1624-14
Openfda › Package ndc › 270169-4915-32
Openfda › Package ndc › 280169-4915-03
Openfda › Package ndc › 290169-4404-31
Openfda › Package ndc › 300169-4415-31
Openfda › Package ndc › 310169-4415-92
Openfda › Package ndc › 320169-4409-31
Openfda › Package ndc › 330169-4425-31
Openfda › Product ndc › 10169-1602
Openfda › Product ndc › 20169-4525
Openfda › Product ndc › 30169-4505
Openfda › Product ndc › 40169-4501
Openfda › Product ndc › 50169-4517
Openfda › Product ndc › 60169-4524
Openfda › Product ndc › 70169-4572
Openfda › Product ndc › 80169-1605
Openfda › Product ndc › 90169-1610
Openfda › Product ndc › 100169-1617
Openfda › Product ndc › 110169-1624
Openfda › Product ndc › 120169-4915
Openfda › Product ndc › 130169-4404
Openfda › Product ndc › 140169-4415
Openfda › Product ndc › 150169-4409
Openfda › Product ndc › 160169-4425
Openfda › Generic nameSEMAGLUTIDE
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Pharm class csGlucagon-Like Peptide 1 [CS]
Openfda › Substance nameSEMAGLUTIDE
Openfda › Pharm class epcGLP-1 Receptor Agonist [EPC]
Openfda › Pharm class moaGlucagon-like Peptide-1 (GLP-1) Agonists [MoA]
Openfda › Manufacturer nameNovo Nordisk Pharmaceutical Industries, LP
Openfda › Application numberNDA215256
Openfda › Is original packagertrue
Event id98100
Address 1800 Scudders Mill Rd
Address 2N/A
Code infoLot #: RZFYK06, RZFYA53; Exp Date 3/31/2027
Postal code08536-1606
Report date20260107
Product typeDrugs
Product quantityN/A
Reason for recallPresence of Particulate Matter: Hair was found in a prefilled syringe
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20251219
Initial firm notificationLetter
Center classification date20251231

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Resumen

  • Empresa ResponsableNovo Nordisk Inc.
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionNationwide within the United States.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: Novo Nordisk Inc. - 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

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https://therecallfile.com/es/recalls/wegovy-semaglutide-injection-1-mg-0-5-ml-4-single-dose-prefilled-pens/FDA-D-0245-2026
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Spread the WordWegovy (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

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