Home/Recalls/FDA-D-0244-2026
FDA DrugsClass II

Wegovy (semaglutide) Injection, 0.5 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 0169-4505-14

Published: January 7, 2026Recall ID: D-0244-2026Category: drugsCountry: US
US
PharmaceuticalFDA DrugsUSUS

Wegovy (semaglutide) Injection, 0.5 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 0169-4505-14

Recalling Firm: Novo Nordisk Inc.

Reason for Recall / Hazard

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

Product Description & Identification

Wegovy (semaglutide) Injection, 0.5 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 0169-4505-14

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 #: RZFHD52, RZFHW93; Exp Date 10/31/2026
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

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Overview

  • Recalling FirmNovo Nordisk Inc.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide within the United States.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: Novo Nordisk Inc. - Wegovy (semaglutide) Injection, 0.5 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 0169-4505-14

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Spread the WordWegovy (semaglutide) Injection, 0.5 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 0169-4505-14

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