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.

226–250 of 917

  • HighFDA (Drugs)·D-0237-2025·2025-02-26

    Atomoxetine Capsules Nationwide Recall for N-Nitroso Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling 39,168 bottles of Atomoxetine 100 mg capsules nationwide due to manufacturing deviations that resulted in N-Nitroso impurity exceeding FDA recommended limits. No illnesses have been reported.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2025·2025-02-19

    Exactech Alteon XLE Hip Replacement Liners Recalled for Missing Barrier Layer

    Exactech is recalling Alteon XLE hip replacement liners due to a manufacturing defect. Some units lack the Ethylene Vinyl Alcohol barrier layer required for proper device function.

    Product
    Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Drugs)·D-0217-2025·2025-02-12

    Carvedilol 25 mg tablets recalled due to N-nitroso impurity above limit

    RemedyRepack Inc. is recalling certain Carvedilol 25 mg tablets because testing found N-nitroso Carvedilol Impurity-1 exceeding FDA's acceptable limit due to manufacturing process deviations.

    Product
    Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1101-2025·2025-02-12

    Dental implants recalled for manufacturing defect affecting sterile packaging

    Nobel Biocare recalled N1 TiUltra TCC dental implants due to a manufacturing defect that may puncture the sterile blister packaging. The defect is a sharp pin created during injection molding that could compromise product sterility.

    Product
    . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0992-2025·2025-02-05

    Medline General Surgery Arterial Line Tray kits recalled for manufacturing defect

    Medline arterial line tray kits (models ART600 and ART690) are being recalled because the catheter hub contains excess material from manufacturing. The recall affects 58 kits distributed nationwide.

    Product
    Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0210-2025·2025-02-05

    FDA Class I Recall: Astagraf XL Immunosuppressant Capsules May Be Empty

    Astellas Pharma is recalling Astagraf XL (tacrolimus) due to manufacturing defects; bottles shipped nationwide may contain empty capsules instead of medication.

    Product
    ASTAGRAF XL — ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0991-2025·2025-02-05

    Medline Arterial Line Insertion Kits Recalled for Catheter Hub Defect

    Medline Industries is recalling 942 arterial line insertion kits due to excess material on the catheter hub of the catheter subassembly. The manufacturing defect prompted a FDA Class I recall of products distributed nationwide.

    Product
    Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0206-2025·2025-01-29

    First Aid Beauty Ultra Repair Cream Recalled for CGMP Deviations

    First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.

    Product
    First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0202-2025·2025-01-22

    FDA recalls glipiZIDE Extended-Release Tablets for failed dissolution specifications

    Amerisource Health Services LLC is recalling glipiZIDE Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications. Patients should contact their pharmacist or healthcare provider.

    Product
    glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0189-2025·2025-01-15

    Duloxetine Delayed-Release Capsules Recalled for Manufacturing Impurity Above Safe Limits

    Rising Pharma is recalling 73,680 bottles of Duloxetine 20 mg capsules nationwide due to N-nitroso-duloxetine impurity above recommended limits from manufacturing deviations. No illnesses have been reported.

    Product
    Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2025·2025-01-15

    Neptune Medical Suction Rovers Recalled Due to Loose Bolts

    Stryker's Neptune 3 and Neptune S Rover surgical suction systems are recalled due to improperly tightened bolts on the vacuum pump filter housing. Loose bolts may cause loss of suction force during medical procedures.

    Product
    100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0817-2025·2025-01-15

    GE Tec Anesthesia Vaporizers Recalled for Insufficient Anesthetic Delivery

    Certain GE Tec anesthesia vaporizers (Tec 6 Plus and Tec 800 series) may deliver less anesthetic agent than the dial indicates due to a manufacturing issue. Users should cease use and contact GE Medical for instructions.

    Product
    Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0751-2025·2025-01-01

    Daytona Small Stature Locking Caps recalled for manufacturing defects

    SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.

    Product
    Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0156-2025·2025-01-01

    Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity Contamination

    Amerisource Health Services is recalling certain lots of Duloxetine Delayed-Release Capsules due to N-nitroso impurity levels exceeding recommended limits. Consumers with the medication should contact their healthcare provider.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2025·2025-01-01

    FDA Recalls Medical Spine Component Due to Manufacturing Defects

    SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.

    Product
    Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0138-2025·2024-12-25

    Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Keystone Industries is recalling Benzocaine 20% topical anesthetic gel due to scratches in the manufacturing mixing vessel. Despite Quality Assurance rejection, the product was inadvertently shipped to customers.

    Product
    M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2025·2024-12-25

    Primo Topical Anesthetic Gel Recalled for Manufacturing Defect

    Primo Topical Anesthetic Gel (Benzocaine 20%) is recalled due to manufacturing defect. A Quality Unit inspection found scratches in the mixing vessel, causing inadvertent release of product that should have been rejected.

    Product
    Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0146-2025·2024-12-25

    Quala Dental Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Quala Dental Products topical anesthetic gel (20% benzocaine) is recalled due to manufacturing equipment defects. The bulk product was inadvertently released despite Quality Unit rejection after inspection found scratches on the mixing vessel.

    Product
    Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0144-2025·2024-12-25

    Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.

    Product
    Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2025·2024-12-25

    GE OEC 9800 X-Ray System Recalled for Insufficient Tube Sealing

    GE OEC 9800 fluoroscopic X-ray systems are recalled due to insufficient sealing of X-ray tubes, which can result in oil leaks and loss of imaging capability. 25 systems distributed in the U.S. and internationally are affected.

    Product
    OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscop
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Drugs)·D-0140-2025·2024-12-25

    Dental City Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Dental City Topical Anesthetic Gel (Benzocaine 20%) is recalled because the product was released and distributed despite failing quality inspection. Scratches were found in the mixing vessel during routine inspection.

    Product
    Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2025·2024-12-25

    FDA Recalls Benzo-Jel Topical Anesthetic Gel Due to Manufacturing Defect

    Henry Schein's Benzo-Jel Topical Anesthetic Gel is being recalled due to manufacturing quality deviations. Scratches were discovered on the mixing vessel after the product had been inadvertently released and distributed to customers.

    Product
    Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0145-2025·2024-12-25

    Topical Anesthetic Gel Recalled for Manufacturing Process Deviation

    Safco SensiCaine Ultra Topical Anesthetic Gel is being recalled due to a manufacturing process deviation. Product that should have been rejected because of damage to the mixing vessel was inadvertently released to customers.

    Product
    SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL — SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0141-2025·2024-12-25

    Patterson Dental Topical Anesthetic Recalled for Manufacturing Quality Defect

    Keystone Industries is recalling one lot of Patterson Dental Topical Anesthetic due to manufacturing quality deviations. The product was shipped despite being marked for rejection due to scratches in the mixing vessel.

    Product
    PATTERSON DENTAL TOPICAL ANESTHETIC — PATTERSON DENTAL TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide