Wegovy Injection, Solution
FDA Recall NDC 0169-4501
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Wegovy (NDC 0169-4501). A significant event, classified as Class II, was initiated on Dec 19, 2025 by Novo Nordisk Pharmaceutical Industries, Lp. The reported reason for this action was: "Presence of Particulate Matter: Hair was found in a prefilled syringe"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Particulate Matter: Hair was found in a prefilled syringe
Dec 19, 2025
Jan 07, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98100
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Novo Nordisk Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States.
Product Description
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
Batch or Lot Expiration Information
Lot# : RZFYK06, RZFYA53; Exp Date 3/31/2027
Affected Packages Involved in this Recall
0169-4525-01Product
0169-4525-14Product
0169-4525-90Product
0169-4525-94Product
0169-4505-01Product
0169-4505-14Product
0169-4501-01Product
0169-4501-14Product
0169-4517-01Product
0169-4517-14Product
0169-4524-01Product
0169-4524-14Product
0169-4572-01Product
0169-4572-14Product
0169-1602-01Product
0169-1602-14Product
0169-1602-90Product
0169-1602-94Product
0169-1605-01Product
0169-1605-14Product
0169-1610-01Product
0169-1610-14Product
0169-1617-01Product
0169-1617-14Product
0169-1624-01Product
0169-1624-14Product
0169-4404-31Product
0169-4415-31Product
0169-4415-92Product
0169-4409-31Product
0169-4425-31Product
Class II Ongoing
Presence of Particulate Matter: Hair was found in a prefilled syringe
Dec 19, 2025
Jan 07, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98100
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Novo Nordisk Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States.
Product Description
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
Batch or Lot Expiration Information
Lot# : RZFHD52, RZFHW93; Exp Date 10/31/2026
Affected Packages Involved in this Recall
0169-4525-01Product
0169-4525-14Product
0169-4525-90Product
0169-4525-94Product
0169-4505-01Product
0169-4505-14Product
0169-4501-01Product
0169-4501-14Product
0169-4517-01Product
0169-4517-14Product
0169-4524-01Product
0169-4524-14Product
0169-4572-01Product
0169-4572-14Product
0169-1602-01Product
0169-1602-14Product
0169-1602-90Product
0169-1602-94Product
0169-1605-01Product
0169-1605-14Product
0169-1610-01Product
0169-1610-14Product
0169-1617-01Product
0169-1617-14Product
0169-1624-01Product
0169-1624-14Product
0169-4404-31Product
0169-4415-31Product
0169-4415-92Product
0169-4409-31Product
0169-4425-31Product
Class II Ongoing
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Apr 09, 2025
May 07, 2025
48 Cartons
Recall Profile & Regulatory Data
Event ID
96637
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NC, SC, VA
Product Description
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.
Batch or Lot Expiration Information
Lot# Lot PZFDE06, Exp 08/31/2025
Affected Packages Involved in this Recall
0169-4525-01Product
0169-4525-14Product
0169-4525-90Product
0169-4525-94Product
0169-4505-01Product
0169-4505-14Product
0169-4501-01Product
0169-4501-14Product
0169-4517-01Product
0169-4517-14Product
0169-4524-01Product
0169-4524-14Product
0169-4572-01Product
0169-4572-14Product
0169-1602-01Product
0169-1602-14Product
0169-1602-90Product
0169-1602-94Product
0169-1605-01Product
0169-1605-14Product
0169-1610-01Product
0169-1610-14Product
0169-1617-01Product
0169-1617-14Product
0169-1624-01Product
0169-1624-14Product
0169-4404-31Product
0169-4415-31Product
0169-4415-92Product
0169-4409-31Product
0169-4425-31Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
