FDA DrugsClass II
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Man...
Published: January 7, 2026Recall ID: D-0244-2026Category: drugsCountry: US
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
| Field | Value |
|---|---|
| City | Plainsboro |
| State | NJ |
| Openfda › Nui › 1 | N0000178480 |
| Openfda › Nui › 2 | M0160181 |
| Openfda › Nui › 3 | N0000020058 |
| Openfda › Unii | 53AXN4NNHX |
| Openfda › Route | SUBCUTANEOUS |
| Openfda › Spl id | f38985f6-b16a-426b-9c0d-6d4815acebfe |
| Openfda › Brand name | WEGOVY |
| Openfda › Spl set id | ee06186f-2aa3-4990-a760-757579d8f77b |
| Openfda › Package ndc › 1 | 0169-4525-01 |
| Openfda › Package ndc › 2 | 0169-4525-14 |
| Openfda › Package ndc › 3 | 0169-4525-90 |
| Openfda › Package ndc › 4 | 0169-4525-94 |
| Openfda › Package ndc › 5 | 0169-4505-01 |
| Openfda › Package ndc › 6 | 0169-4505-14 |
| Openfda › Package ndc › 7 | 0169-4501-01 |
| Openfda › Package ndc › 8 | 0169-4501-14 |
| Openfda › Package ndc › 9 | 0169-4517-01 |
| Openfda › Package ndc › 10 | 0169-4517-14 |
| Openfda › Package ndc › 11 | 0169-4524-01 |
| Openfda › Package ndc › 12 | 0169-4524-14 |
| Openfda › Package ndc › 13 | 0169-4572-01 |
| Openfda › Package ndc › 14 | 0169-4572-14 |
| Openfda › Package ndc › 15 | 0169-1602-01 |
| Openfda › Package ndc › 16 | 0169-1602-14 |
| Openfda › Package ndc › 17 | 0169-1602-90 |
| Openfda › Package ndc › 18 | 0169-1602-94 |
| Openfda › Package ndc › 19 | 0169-1605-01 |
| Openfda › Package ndc › 20 | 0169-1605-14 |
| Openfda › Package ndc › 21 | 0169-1610-01 |
| Openfda › Package ndc › 22 | 0169-1610-14 |
| Openfda › Package ndc › 23 | 0169-1617-01 |
| Openfda › Package ndc › 24 | 0169-1617-14 |
| Openfda › Package ndc › 25 | 0169-1624-01 |
| Openfda › Package ndc › 26 | 0169-1624-14 |
| Openfda › Package ndc › 27 | 0169-4915-32 |
| Openfda › Package ndc › 28 | 0169-4915-03 |
| Openfda › Package ndc › 29 | 0169-4404-31 |
| Openfda › Package ndc › 30 | 0169-4415-31 |
| Openfda › Package ndc › 31 | 0169-4415-92 |
| Openfda › Package ndc › 32 | 0169-4409-31 |
| Openfda › Package ndc › 33 | 0169-4425-31 |
| Openfda › Product ndc › 1 | 0169-1602 |
| Openfda › Product ndc › 2 | 0169-4525 |
| Openfda › Product ndc › 3 | 0169-4505 |
| Openfda › Product ndc › 4 | 0169-4501 |
| Openfda › Product ndc › 5 | 0169-4517 |
| Openfda › Product ndc › 6 | 0169-4524 |
| Openfda › Product ndc › 7 | 0169-4572 |
| Openfda › Product ndc › 8 | 0169-1605 |
| Openfda › Product ndc › 9 | 0169-1610 |
| Openfda › Product ndc › 10 | 0169-1617 |
| Openfda › Product ndc › 11 | 0169-1624 |
| Openfda › Product ndc › 12 | 0169-4915 |
| Openfda › Product ndc › 13 | 0169-4404 |
| Openfda › Product ndc › 14 | 0169-4415 |
| Openfda › Product ndc › 15 | 0169-4409 |
| Openfda › Product ndc › 16 | 0169-4425 |
| Openfda › Generic name | SEMAGLUTIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Glucagon-Like Peptide 1 [CS] |
| Openfda › Substance name | SEMAGLUTIDE |
| Openfda › Pharm class epc | GLP-1 Receptor Agonist [EPC] |
| Openfda › Pharm class moa | Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] |
| Openfda › Manufacturer name | Novo Nordisk Pharmaceutical Industries, LP |
| Openfda › Application number | NDA215256 |
| Openfda › Is original packager | true |
| Event id | 98100 |
| Address 1 | 800 Scudders Mill Rd |
| Address 2 | N/A |
| Code info | Lot #: RZFHD52, RZFHW93; Exp Date 10/31/2026 |
| Postal code | 08536-1606 |
| Report date | 20260107 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Presence of Particulate Matter: Hair was found in a prefilled syringe |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | Letter |
| Center classification date | 20251231 |
Overview
- Recalling FirmNovo Nordisk Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States.