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.

526–550 of 1441

  • ModerateFDA (Drugs)·D-0385-2023·2023-03-08

    FDA Recalls Dofetilide Antiarrhythmic Drug for Manufacturing Deviations

    Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing compliance deviations identified during FDA inspection. The recall affects approximately 113,003 bottles distributed in the U.S., Puerto Rico, and Canada.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0410-2023·2023-03-08

    Simvastatin Tablets Recalled Due to Manufacturing Practice Deviations

    Accord Healthcare is recalling Simvastatin 20 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. The recall affects 1,394,208 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    SIMVASTATIN — SIMVASTATIN (SIMVASTATIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0378-2023·2023-03-08

    Accord Healthcare Recalls Buspirone Hydrochloride Tablets Due to Manufacturing Violations

    Accord Healthcare is recalling Buspirone Hydrochloride tablets due to manufacturing process deviations found during an FDA inspection. The recall affects approximately 3,784 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0375-2023·2023-03-08

    Buspirone Hydrochloride tablets recalled for manufacturing practice deviations

    Accord Healthcare is recalling Buspirone Hydrochloride 7.5 mg tablets (23,784 bottles) distributed in the US, Puerto Rico, and Canada due to manufacturing practice deviations identified during FDA inspection.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0418-2023·2023-03-08

    Vigabatrin Oral Solution Recalled for Manufacturing Quality Deviations

    Accord Healthcare is recalling 821 cartons of Vigabatrin for Oral Solution due to manufacturing quality deviations found during an FDA inspection. The product was distributed in the United States, Puerto Rico, and Canada.

    Product
    Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0419-2023·2023-03-08

    Pirfenidone tablets recalled due to manufacturing process deviations

    Accord Healthcare recalls Pirfenidone tablets due to manufacturing practice deviations found during FDA inspection. The recall affects 2,614 cartons distributed in the US, Puerto Rico, and Canada.

    Product
    PIRFENIDONE — PIRFENIDONE (PIRFENIDONE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0430-2023·2023-03-08

    Ropinirole Tablets Recalled Due to Manufacturing Practice Deviations

    Accord Healthcare is recalling 8,184 bottles of Ropinirole 4 mg tablets due to manufacturing practice deviations found during an FDA inspection. The recalled batches were distributed in the United States, Puerto Rico, and Canada.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1159-2023·2023-03-01

    IV Start Kit Recalled Due to Connector Manufacturing Defect

    Cardinal Health Presource Packs IV start kits with ICU MicroClave Clear Connectors are being recalled due to a manufacturing defect that may cause fluid leaks and loss of fluid path integrity.

    Product
    Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1158-2023·2023-03-01

    IV Access Device Kit Recalled Due to Manufacturing Defect in Connector

    Cardinal Health is recalling Presource Packs IV START TRAY I kits due to a manufacturing defect in the ICU MicroClave Clear Connector that may cause fluid leaks and loss of fluid path integrity.

    Product
    Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0270-2023·2023-02-22

    New & Improved Blue Gel Anesthetic Recalled Nationwide for API Discoloration

    HTO Nevada, Inc. is recalling 4,709 bottles of New & Improved Blue Gel Anesthetic nationwide due to discoloration of the epinephrine active pharmaceutical ingredient resulting from a cGMP deviation in the raw material supply.

    Product
    New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code: 80069-008-01. Drug Facts- For use by licensed professionals only, Active…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0271-2023·2023-02-22

    FDA Recalls Maximum Zone2 Topical Analgesic Due to Epinephrine Discoloration

    HTO Nevada's Maximum Zone2 Topical Analgesic (1oz, Lot #795CP-0003, NDC 80069-012-01) is recalled nationwide in the USA and Canada due to discoloration of the epinephrine active ingredient caused by a manufacturing deviation.

    Product
    Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2023·2023-02-15

    Vascular Covered Stent Recalled Due to Deployment Failure Risk

    Bard Peripheral Vascular Inc is recalling approximately 10,815 Covera Vascular Covered Stent devices due to poor slide block bonding that may prevent proper deployment during vascular procedures.

    Product
    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0257-2023·2023-02-08

    Easy Clean Isopropyl Alcohol Recalled for Manufacturing Practice Deviations

    Frenda Corporation is recalling Easy Clean 70% Isopropyl Alcohol due to manufacturing practice deviations. The recall affects 65,376 bottles distributed in Puerto Rico.

    Product
    Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0261-2023·2023-02-08

    Homeopathic Topical Cream Recalled for Manufacturing Process Deviations

    DISCOVERY PHARMA LLC voluntarily recalled 21,892 tubes of Conzerol zero molluscum contagiosum topical cream distributed in California, Florida, and Washington due to current good manufacturing practice deviations.

    Product
    Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8 60322 00180 8, Manufactured by: Dr. Retter EC Warszawska 17, 05-075 Warszawa Poland
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0225-2023·2023-02-01

    Injectable NADH Recalled for Sterility Concerns at Manufacturing Facility

    Pharmacy Innovations is recalling NADH 10MG/ML injectable vials distributed nationwide due to lack of assurance of sterility. FDA inspection revealed insanitary conditions at the facility.

    Product
    NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0207-2023·2023-02-01

    Injectable Ethyl Alcohol 95% Recalled Due to Sterility Assurance Concerns

    Pharmacy Innovations is recalling Ethyl Alcohol 95% (5ML vial) Injectable nationwide because FDA inspection revealed insanitary conditions at the manufacturing facility that compromise sterility assurance.

    Product
    Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0133-2023·2023-01-25

    Drug Recall: Artificial Tears Eye Ointment Due to Manufacturing Deviations

    Akorn, Inc. is recalling Artificial Tears Ointment (1.16 million tubes nationwide) due to manufacturing practice deviations. The firm voluntarily initiated this recall.

    Product
    Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2023·2023-01-25

    FDA Recalls Nationwide Supply of Erythromycin Ophthalmic Ointment for Manufacturing Deviations

    Akorn, Inc. is recalling 36,455 cartons of Erythromycin Ophthalmic Ointment USP 0.5% nationwide due to manufacturing process deviations. The company voluntarily initiated this Class II recall.

    Product
    Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2023·2023-01-25

    FDA Recalls Akorn AK-POLY-BAC Eye Ointment for CGMP Violations

    Akorn Inc. voluntarily recalls 36,025 tubes of AK-POLY-BAC Bacitracin/Polymixin B eye ointment nationwide due to manufacturing process deviations affecting product quality and sterility.

    Product
    AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0141-2023·2023-01-25

    Ketorolac Tromethamine ophthalmic solution recalled due to manufacturing deviations

    Akorn is recalling Ketorolac Tromethamine Ophthalmic Solution nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers of the 0.5% formulation.

    Product
    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0157-2023·2023-01-25

    Prescription Eye Drops Recalled for Manufacturing Control Deviations

    Akorn, Inc. is voluntarily recalling over 2 million bottles of Tobramycin Ophthalmic Solution due to Current Good Manufacturing Practice deviations affecting four product lots distributed nationwide.

    Product
    Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0147-2023·2023-01-25

    Eye drop medication Olopatadine HCl recalled nationwide for manufacturing deviations

    Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl ophthalmic solution nationwide due to current good manufacturing practice deviations. This voluntary recall was initiated by the manufacturer.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0166-2023·2023-01-25

    Hand Sanitizer Recalled for Chemical Impurities and Manufacturing Defects

    SIREtizer Hand Sanitizer is recalled for containing acetal and acetaldehyde above allowable limits and manufacturing defects, including one superpotent lot.

    Product
    SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th…
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0150-2023·2023-01-25

    Antihistamine eye drops recalled due to manufacturing process deviations

    Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0137-2023·2023-01-25

    FDA Recalls Cromolyn Sodium Eye Drops Nationwide for Manufacturing Defects

    Akorn, Inc. is recalling 188,550 bottles of Cromolyn Sodium Ophthalmic Solution nationwide due to manufacturing quality control deviations.

    Product
    Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
    Category
    Drug
    Distribution
    Distributed nationwide