The Recall Desk

Hazard

Manufacturing Defect recalls

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

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 917

  • HighFDA (Devices)·Z-0146-2026·2025-10-22

    Electrosurgical unit recalled nationwide due to manufacturing defects

    Lutronic Corporation is recalling 7,490 XERF EFFECTOR 60 electrosurgical units manufactured from April through August 2025 due to manufacturing defects that can result in adverse patient events. The recall includes units distributed in the US and multiple international locations.

    Product
    XERF EFFECTOR 60. Electrosurgical unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2026·2025-10-22

    FRED Flow Diverter Devices Recalled for Manufacturing Defect Risk

    MICROVENTION is recalling specific FRED 27 and FRED X 27 flow diverter devices due to a manufacturing issue affecting tantalum length or attachment pattern. The defect may prevent proper device positioning in blood vessels, potentially requiring device recapture.

    Product
    Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0056-2026·2025-10-15

    L-Arginine HCl for Injection Recalled for Lack of Sterility Assurance

    GenoGenix LLC is recalling L-Arginine HCl for Injection due to lack of sterility assurance. The recall affects all strengths and presentations distributed nationwide.

    Product
    L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2025·2025-10-08

    JETT Blood Flow Occlusion Devices Recalled for Manufacturing Defect

    North American Rescue is recalling 552 JETT devices used to control bleeding in limbs due to a potential manufacturing defect that may compromise device performance during use.

    Product
    JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0662-2025·2025-10-01

    Azelaic Acid Gel Recall Due to Manufacturing Quality Defect

    Glenmark Pharmaceuticals recalls 13,824 tubes of Azelaic Acid Gel due to complaints of gritty texture resulting from manufacturing process deviations.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2025·2025-09-17

    LinkSymphoKnee Tibial Component Recalled Due to Uncoated Security Screws

    Waldemar Link is recalling 8 LinkSymphoKnee knee prosthetic components manufactured with uncoated security screws instead of coated screws. Uncoated screws in the implant present a risk of corrosion and potential implant failure.

    Product
    LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2025·2025-09-17

    Merit Medical 10Fore Hemostasis Valve Recalled Due to Manufacturing Defect

    Merit Medical is recalling 10Fore Hemostasis Valves due to a manufacturing defect where the silicone quad ring may be deformed or damaged, posing a risk of foreign body in the fluid pathway.

    Product
    10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2025·2025-09-17

    Boston Scientific Preventive Maintenance Kit ICEFX Recalled for Loose End Caps

    Boston Scientific is recalling the Preventive Maintenance Kit ICEFX because certain desiccant tube subassemblies have end caps that were not correctly tightened during manufacturing. The affected batch was distributed in Canada, France, Germany, Italy, and the United States.

    Product
    Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0637-2025·2025-09-17

    Chlorpromazine Hydrochloride Tablets Recalled for Manufacturing Defect Impurity

    Zydus Pharmaceuticals recalls Chlorpromazine Hydrochloride 100 mg tablets nationwide due to manufacturing deviations resulting in N-Nitroso Desmethyl Chlorpromazine impurity above acceptable limits.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2514-2025·2025-09-10

    Dental Implant Titanium Base Recalled for Manufacturing Misalignment

    Preat Corp is recalling NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base units due to a manufacturing defect causing 180-degree misalignment. The error prevents dental crowns from fitting properly onto the abutment, resulting in restoration delays.

    Product
    NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2451-2025·2025-09-03

    Intraocular lenses with incorrect power recalled for vision impairment risk

    Bausch & Lomb is recalling Akreos intraocular lenses due to a manufacturing error that resulted in incorrect lens power (16 diopters instead of 3), which could cause vision problems requiring optical or surgical correction.

    Product
    Akreos, SKU: AO60P0300. Akreos intraocular lenses
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0589-2025·2025-08-27

    BZK Antiseptic Towelettes Recalled for Lack of Sterility Assurance

    Taizhou Kangping Medical is recalling 3.85 million cartons of BZK Antiseptic Towelettes due to lack of assurance of sterility. The product is intended for external wound care by healthcare professionals.

    Product
    BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0590-2025·2025-08-27

    Epinephrine Injection Vials Recalled Over Sterility Assurance Issue

    Pfizer is recalling 49,620 vials of Epinephrine Injection nationwide due to lack of sterility assurance. Affected lots are LY3681, LY4360, and LY4416, expiring 02/28/2026.

    Product
    Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0577-2025·2025-08-20

    Carvedilol tablets recalled nationwide due to nitrosamine impurity

    Glenmark Pharmaceuticals is recalling Carvedilol 3.125 mg tablets due to nitrosamine impurity above acceptable levels. Approximately 44,328 bottles were distributed nationwide.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0580-2025·2025-08-20

    Prescription drug duloxetine recalled for chemical impurity above FDA limits

    Breckenridge Pharmaceutical is recalling duloxetine 60 mg capsules due to N-nitroso-duloxetine impurity exceeding FDA recommended limits. Approximately 1,856 bottles distributed to New Jersey, Arizona, and Indiana.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0581-2025·2025-08-20

    Metoprolol Tartrate Tablets Recalled for Nitrosamine Contamination Above Safety Limits

    Westminster Pharmaceuticals is recalling Metoprolol Tartrate 50 mg tablets nationwide due to contamination with N-nitroso-metoprolol exceeding safe intake limits. About 16,672 bottles are affected across multiple batches.

    Product
    METOPROLOL TARTRATE — METOPROLOL TARTRATE (METOPROLOL TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2025·2025-08-20

    Carvedilol tablets recalled nationwide for excess N-nitroso impurity

    Glenmark Pharmaceuticals is recalling 17,496 bottles of Carvedilol 12.5 mg tablets nationwide due to manufacturing defects. Tests found N-nitroso impurity levels above FDA limits.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0447-2025·2025-08-20

    Lithium Orotate Dietary Supplement Recalled for Out-of-Specification Manufacturing

    GMP Laboratories of America Inc is recalling Lithium Orotate dietary supplements (2.5 mg and 10 mg) due to manufacturing out of specifications. The product was distributed to a single customer in California and Oklahoma.

    Product
    Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LLC. 447 Sutter St., Suite 405, San Fransisco, CA 94108 2.5 mg UPC#: X002T4OPLL 10 mg UPC#: X0031AXVE9
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·H-0448-2025·2025-08-20

    Lithium Orotate Supplement Recalled Due to Out-of-Specification Manufacturing

    GMP Laboratories is recalling Lithium Orotate dietary supplements manufactured out of specification. Approximately 185,482 capsules were distributed to customers in California and Oklahoma.

    Product
    Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian capsules, Dietary Supplement; Distributed by Enjoy Nutirtion, LLC. San Francisco, CA 94108, (415) 894-0537 2.5 mg UPC#: X001SBI13J 5 mg UPC#: X000PY16Z5 10 mg UPC#: X000T9B9B7 20 mg UPC#: X001VBLW8H 1000 MCG UPC#: X003SBV
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0559-2025·2025-08-13

    Tirzepatide + Niacinamide Injectable Recalled for Manufacturing Control Deficiency

    Aequita Pharmacy is recalling 143 vials of Tirzepatide + Niacinamide injection solution due to inadequate processing controls during manufacturing. The medication was distributed in Massachusetts.

    Product
    Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0563-2025·2025-08-13

    Semaglutide Injection Recalled for Manufacturing Process Control Deficiency

    Aequita Pharmacy is recalling 190 vials of Semaglutide + Cyanocobalamin injection due to inadequate manufacturing process controls. Affected vials were distributed in Massachusetts.

    Product
    Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0554-2025·2025-08-13

    Injectable Tirzepatide-Niacinamide Compound Recalled for Lack of Manufacturing Controls

    Aequita Pharmacy recalls 236 vials of compounded Tirzepatide-Niacinamide injectable due to lack of manufacturing process controls. Affected vials were distributed in Massachusetts.

    Product
    Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0556-2025·2025-08-13

    Aequita Pharmacy Recalls Tirzepatide + Niacinamide Injections Due to Manufacturing Control Issues

    Aequita Pharmacy is recalling Tirzepatide + Niacinamide injection solution due to lack of manufacturing process controls. Anyone currently using this medication should contact their healthcare provider.

    Product
    Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2190-2025·2025-08-06

    BostonSight Scleral Contact Lenses Recall Due to Manufacturing Defects

    Boston Foundation For Sight is recalling 441 units of BostonSight SCLERAL contact lenses manufactured with errors affecting lens height and edge fit parameters.

    Product
    BostonSight SCLERAL Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide