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.

151–175 of 917

  • HighFDA (Drugs)·D-0544-2025·2025-08-06

    Pfizer Recalls Bicillin L-A Injectable Antibiotic Due to Manufacturing Particulates

    Pfizer is recalling Bicillin L-A (penicillin G benzathine) injectable antibiotic nationwide due to particulates identified during manufacturing quality inspections. The affected vials may contain visible foreign particles.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-2230-2025·2025-08-06

    FDA Recalls RAPIDPoint 500 Wash/Waste Cartridge for Inaccurate Test Results

    Siemens recalls RAPIDPoint 500 wash/waste cartridges due to manufacturing errors that may cause inaccurate blood test results in clinical laboratories.

    Product
    RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2025·2025-07-30

    Estrone RIA diagnostic kits recalled for falsely elevated test results

    Beckman Coulter recalls Estrone RIA kits due to manufacturing defects in coated tubes causing falsely elevated estrone measurements. Affected lots were distributed in North Carolina and internationally.

    Product
    Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2163-2025·2025-07-30

    Johnson & Johnson recalls Acuvue Oasys Max contact lenses for manufacturing defects

    Johnson & Johnson Vision Care is recalling 114,165 Acuvue Oasys Max 1-Day Multifocal contact lenses due to bubbles and voids found during quality testing. The defects were identified during standard finished goods inspection.

    Product
    ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0534-2025·2025-07-23

    Rizatriptan benzoate tablets recalled for manufacturing defect with chemical impurity

    Ascend Laboratories is recalling Rizatriptan Benzoate 10 mg tablets nationwide due to elevated levels of a chemical impurity detected during manufacturing. The impurity exceeds FDA acceptable intake limits.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2083-2025·2025-07-16

    Edwards FEM-FLEX II Femoral Cannula Recalled for Exposed Wire Defect

    Edwards Lifesciences is recalling the FEM-FLEX II Femoral Arterial Cannula due to exposed wire segments protruding from the device body. The defect poses a mechanical hazard during arterial perfusion procedures.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0512-2025·2025-07-16

    B Natural Organics Sunscreen Recalled for Manufacturing Quality Deviations

    B Natural Organics Sunscreen products are being recalled due to manufacturing process deviations. The recall affects specific lots distributed in New Jersey, Florida, and Michigan.

    Product
    B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-2108-2025·2025-07-16

    Alcon Constellation Vitrectomy Procedure Pak Recalled for Potential Manufacturing Defect

    Alcon Laboratories is recalling specific lots of Constellation Vision System Vitrectomy Procedure Paks due to potential manufacturing damage to the lidding that could compromise sterility.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0501-2025·2025-07-09

    KETAmine Injection Recall Due to Sterility Manufacturing Concerns

    Tailstorm Health INC is recalling KETAmine Hydrochloride Injection due to sterility assurance concerns identified during FDA inspection. The recall affects 14,725 vials distributed nationwide.

    Product
    KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0503-2025·2025-07-09

    Lidocaine HCL Sterile Injection Recalled Due to Sterility Assurance Concerns

    Tailstorm Health is recalling LIDOcaine HCL Sterile Injection (20 mg/mL, 10mL vials) nationwide due to lack of assurance of sterility identified during FDA inspection. No illnesses have been reported.

    Product
    LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0498-2025·2025-07-09

    Lidocaine HCl Injection recalled for sterility assurance concerns

    Tailstorm Health is recalling Lidocaine HCl Injection vials nationwide due to concerns with the sterile manufacturing process identified during FDA inspection.

    Product
    LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 8522
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0500-2025·2025-07-09

    Ketamine Injection Recalled Due to Sterility Assurance Concerns

    Tailstorm Health is recalling Ketamine Hydrochloride Injection due to manufacturing process concerns that could affect product sterility. The recall involves 23,200 vials distributed nationwide.

    Product
    KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2025·2025-06-25

    Dental implant abutments recalled for improper screw seat manufacturing defect

    Preat Corp is recalling 145 Biomet 3i dental implant abutments due to a manufacturing defect where the screw seat is positioned too high, potentially reducing screw engagement and affecting implant stability.

    Product
    Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2025·2025-06-25

    Optima Coil System embolization devices recalled for defective radiopaque markers

    BALT USA is recalling Optima Coil System implants due to radiopaque markers not being visible during angiography. The markers were not manufactured to specification.

    Product
    Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2025·2025-06-25

    Prestige Coil embolization coils recalled for defective radiopaque markers

    Prestige Coil System embolization coils are recalled due to faulty radiopaque markers that are not visible during angiography. The defect may impair physician visualization during coil placement.

    Product
    Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 0081006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0471-2025·2025-06-25

    Amazon Basic Care Acetaminophen Tablets Recalled for Manufacturing Defects

    Amazon Basic Care Acetaminophen tablets are being recalled due to manufacturing deviations that resulted in tablet discoloration. No illnesses have been reported.

    Product
    AMAZON BASIC CARE ACETAMINOPHEN — AMAZON BASIC CARE ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2025·2025-06-18

    Stryker Gamma4 Right Long Nails Recalled for Wrong Geometry Manufacturing Defect

    Stryker is recalling certain Gamma4 Long Nails because right-side nails were manufactured with left-side geometry, which could affect proper surgical placement.

    Product
    Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2025·2025-06-11

    Sample probe defect causes inaccurate laboratory measurement results

    Beckman Coulter sample probes with manufacturing defects prevent proper sample handling, causing dilution and inaccurate lab test results. Over 10,000 affected units distributed worldwide.

    Product
    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0455-2025·2025-06-11

    Prescription Fluoxetine tablets recalled for N-nitroso manufacturing defect

    Torrent Pharma Inc. is recalling Fluoxetine 20 mg tablets distributed nationwide due to Current Good Manufacturing Practice deviations resulting in N-nitroso impurity exceeding the FDA's interim acceptable intake limit.

    Product
    FLUOXETINE — FLUOXETINE (FLUOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0449-2025·2025-06-04

    Prescription Drug Recall: Carvedilol Tablets Due to Manufacturing Impurity

    Glenmark Pharmaceuticals recalls Carvedilol 6.25 mg tablets nationwide due to N-Nitroso Carvedilol I impurity above acceptable limits from manufacturing process deviations. No illnesses have been reported.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0451-2025·2025-06-04

    Carvedilol Tablets Recalled for N-Nitroso Impurity Above Acceptable Limits

    Glenmark Pharmaceuticals is recalling 18,696 bottles of Carvedilol 25mg tablets nationwide due to manufacturing violations and N-nitroso impurity above acceptable intake limits. Affected lots are 19231107, 19231114, 19231152, and 19234866.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2025·2025-05-28

    BD Cathena IV Catheters recalled due to septum defect causing blood leakage

    Becton Dickinson is recalling BD Cathena Safety IV Catheters due to a manufacturing defect that may create a hole in the septum, potentially causing blood leakage during insertion.

    Product
    BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
    Category
    Medical Device
    Distribution
    Distributed nationwide