The Recall Desk

Hazard

Manufacturing Defect recalls

1,441 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,441
Critical
7
Severe
114
Most recent
2026-10-21

Of the 1,441 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 114 (8%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

126–150 of 1441

  • ModerateFDA (Drugs)·D-0315-2025·2025-04-16

    Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects lot #17230819 with expiration date March 2025, distributed nationwide.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0316-2025·2025-04-16

    Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc. is recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, expiring Mar-25) distributed nationwide due to current Good Manufacturing Practice (CGMP) deviations. Patients taking this medication should consult their physician before discontinuing use.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0352-2025·2025-04-16

    Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, exp. Mar-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0321-2025·2025-04-16

    Lacosamide Tablets 200mg Recalled Due to CGMP Deviations

    Glenmark Pharmaceuticals is recalling Lacosamide Tablets 200mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and affects specific lot numbers with expiration dates ranging from April 2025 to April 2026.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0319-2025·2025-04-16

    Voriconazole Tablets 50mg Recalled Due to CGMP Deviations

    Glenmark Pharmaceuticals Inc. USA is recalling Voriconazole Tablets 50mg (Lot # 17231045, exp. date Apr-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

    Product
    VORICONAZOLE — VORICONAZOLE (VORICONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0327-2025·2025-04-16

    Fluphenazine Hydrochloride Tablets 2.5mg Recalled by Glenmark Pharmaceuticals

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets 2.5mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot is 17232214 with expiration date September 2025.

    Product
    FLUPHENAZINE HYDROCHLORIDE — FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0337-2025·2025-04-16

    Lacosamide Tablets 50mg Recalled for CGMP Manufacturing Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Lacosamide Tablets 50mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lots distributed nationwide.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0329-2025·2025-04-16

    Glenmark Pharmaceuticals Recalls Indomethacin Capsules for Manufacturing Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Indomethacin Extended-Release Capsules (75mg) distributed nationwide due to Good Manufacturing Practice deviations identified during FDA oversight.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0335-2025·2025-04-16

    Drug Recall: Ranolazine Extended-Release Tablets Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Ranolazine Extended-Release 1000mg tablets (Lot 17240040) nationwide due to manufacturing deviations. This is a voluntary, firm-initiated recall.

    Product
    RANOLAZINE — RANOLAZINE (RANOLAZINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0339-2025·2025-04-16

    Rosuvastatin Calcium Tablets Recalled Nationwide Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Rosuvastatin Calcium 40mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lot numbers expiring February through June 2026.

    Product
    ROSUVASTATIN CALCIUM — ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0334-2025·2025-04-16

    Teriflunomide Tablets 14mg Recalled for CGMP Manufacturing Deviations

    Glenmark Pharmaceuticals Inc. is voluntarily recalling Teriflunomide 14mg tablets (Lot #17232462, expiring Nov-25) distributed nationwide due to current good manufacturing practice (CGMP) deviations discovered during production.

    Product
    TERIFLUNOMIDE — TERIFLUNOMIDE (TERIFLUNOMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0326-2025·2025-04-16

    Fluphenazine Hydrochloride Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets, 10mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects one lot distributed nationwide.

    Product
    FLUPHENAZINE HYDROCHLORIDE — FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0345-2025·2025-04-16

    FDA Recalls Saxagliptin Tablets Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Saxagliptin 2.5mg tablets nationwide due to manufacturing quality issues. The firm initiated this voluntary recall on March 13, 2025.

    Product
    SAXAGLIPTIN — SAXAGLIPTIN (SAXAGLIPTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2025·2025-04-09

    Ethicon Surgical Sutures Recalled Due to Silicone Curing Manufacturing Defect

    Ethicon Endo Surgery recalls approximately 1,080 surgical sutures due to silicone curing issues identified during manufacturing. The defect may affect suture performance during surgical use.

    Product
    PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2025·2025-04-09

    Ethicon PROLENE BLU Surgical Sutures Recalled for Manufacturing Defect

    Ethicon is recalling specific lots of PROLENE BLU surgical sutures due to silicone curing issues during needle manufacturing.

    Product
    PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2025·2025-04-09

    Surgical Suture Recall Due to Silicone Curing Defect

    Ethicon Endo Surgery recalls ETHIBOND EXCEL surgical sutures worldwide due to curing issues with the silicone coating on the needles identified during manufacturing.

    Product
    ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1513-2025·2025-04-09

    Surgical Suture Needles Recalled Due to Manufacturing Defect

    Ethicon Endo Surgery recalls PDS PLUS VIO surgical sutures with needles due to silicone curing defects during manufacturing. 792 units were distributed worldwide.

    Product
    PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2025·2025-04-02

    Medline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect

    Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.

    Product
    namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2025·2025-04-02

    Medline Namic Convenience Kits Pressure Monitoring Lines Recalled for Manufacturing Defect

    Medline is recalling 4400 Namic convenience kits with Pressure Monitoring Lines because the female luer fittings were manufactured with excess material near the fluid pathway.

    Product
    namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1430-2025·2025-04-02

    Pressure Monitoring Lines Recalled for Manufacturing Defect in Luer Fittings

    Medline Industries is recalling namic medical convenience kits containing Pressure Monitoring Lines with defective female luer fittings manufactured with excess material. The defect could impair device function.

    Product
    namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2025·2025-04-02

    Medline Pressure Monitoring Kits Recalled for Luer Fitting Manufacturing Defect

    Medline Industries is recalling 1,669 pressure monitoring line convenience kits distributed worldwide. The female luer fittings contain excess material near the fluid pathway.

    Product
    namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511; 3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323; 4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676; 5) MTS,LEFT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1278-2025·2025-03-26

    Smiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect

    Smiths Medical has recalled 643 ProPort Plastic implantable venous access ports that may separate due to a manufacturing defect. The recall affects units distributed worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1286-2025·2025-03-26

    Smiths Medical ProPort Implantable Port May Separate Due to Manufacturing Defect

    Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.

    Product
    smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1287-2025·2025-03-26

    Smiths Medical ProPort Venous Ports Recalled for Potential Housing Separation

    Smiths Medical is recalling ProPort Low Profile Plastic Venous Access Systems because the plastic port housing and reservoir may separate due to a manufacturing defect. Approximately 8,515 units worldwide are affected.

    Product
    smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1284-2025·2025-03-26

    Smiths Medical ProPort Venous Access System Recalled for Port Separation Risk

    Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
    Category
    Medical Device
    Distribution
    0 states