The Recall Desk

Hazard

Manufacturing Defect recalls

1,434 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,434
Critical
7
Severe
107
Most recent
2026-09-09

Of the 1,434 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 107 (7%) 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.

651–675 of 1434

  • HighFDA (Devices)·Z-1174-2022·2022-06-08

    Single Shot Epidural Tray Kits Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.

    Product
    Single Shot Epidural Tray - 18G Catalog Number: 8139R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2022·2022-06-08

    Epidural Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.

    Product
    Single Shot Epidural Tray Catalog Number: 6183R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.

    Product
    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2022·2022-06-08

    Busse Convenience Kits Recalled: Drug Swabs Face Manufacturing Validation Uncertainty

    Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.

    Product
    Nerve Block Tray Catalog Number: 6796R3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1197-2022·2022-06-08

    Drug Swab Products Recalled for Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products made by PDI are being recalled due to uncertainty about validation testing adequacy in manufacturing. Users should discontinue use of affected lot numbers.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B7345R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1181-2022·2022-06-08

    Medical swab insertion tray recalled due to manufacturing validation uncertainty

    Busse Hospital Disposables recalls swab insertion trays due to uncertainty about manufacturing test method validation. The Class II recall affects products nationwide.

    Product
    SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2022·2022-06-08

    FDA Recalls Swab Products for Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick products from Professional Disposables International have been recalled by the FDA due to uncertainty about adequate validation of manufacturing test methods.

    Product
    SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1195-2022·2022-06-08

    Convenience Kits with Drug Swab Products Recalled for Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products are being recalled nationwide due to uncertainty about the adequacy of the validation of manufacturing test methods.

    Product
    Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0893-2022·2022-06-01

    Losartan Potassium and Hydrochlorothiazide Recall: Impurity Levels Above Acceptable Limits

    Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels above acceptable limits resulting from manufacturing deviations. Patients should consult their healthcare provider regarding their medication.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0894-2022·2022-06-01

    Blood Pressure Medication Recalled for Manufacturing Impurity

    Direct Rx is recalling batches of Losartan Potassium/Hydrochlorothiazide tablets due to CGMP deviations with elevated AZIDO impurity levels. The affected product was distributed in Florida.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1089-2022·2022-05-25

    Acetaminophen tablets in first aid kits recalled for contamination risk

    Total Resources International first aid kits containing acetaminophen tablets are being recalled due to potential cross-contamination from manufacturing equipment damage at the tablet supplier.

    Product
    Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16BLU01495, 20HBC01015CCREV3, 20HBC01084GLOWCC. Kit contents include ULTRAtab Laboratories Coated APAP 325 mg (Acetaminophen 325 mg),
    Category
    Drug
    Distribution
    30 states
  • HighFDA (Drugs)·D-0873-2022·2022-05-25

    Accupril Quinapril HCl Tablets Recalled for Elevated Nitrosamine Impurity

    Pfizer is recalling Accupril (Quinapril HCl) 20 mg tablets nationwide and in Puerto Rico due to N-nitrosoquinapril levels exceeding acceptable limits. Affected lots include DX8682 and DG1188.

    Product
    Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0869-2022·2022-05-25

    Acetaminophen Oral Solution Recalled Due to Manufacturing Quality Control Failure

    Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution due to failure to properly investigate failed microbial testing. The recall affects 121,800 unit dose cups distributed in Indiana.

    Product
    Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0840-2022·2022-05-11

    Losartan Potassium tablets recalled for manufacturing impurity above limits

    Lupin Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. Approximately 1,247,067 bottles were affected.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0839-2022·2022-05-11

    Losartan Potassium Tablets Recalled Due to Unacceptable Chemical Impurity Levels

    Lupin Pharmaceuticals is recalling 1.47 million bottles of Losartan Potassium Tablets due to chemical impurities exceeding acceptable limits. The affected batches were distributed nationwide.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0843-2022·2022-05-11

    Losartan Potassium and Hydrochlorothiazide tablets recalled for AZIDO impurity

    Lupin Pharmaceuticals recalls Losartan Potassium and Hydrochlorothiazide tablets nationwide due to manufacturing deviations that resulted in AZIDO impurity levels above acceptable limits.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0836-2022·2022-05-11

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Manufacturing Defect

    Macleods Pharma USA Inc is recalling multiple lots of Losartan Potassium and Hydrochlorothiazide tablets (NDC# 33342-052-07, 33342-052-10, 33342-052-44) distributed nationwide due to AZIDO impurity levels exceeding acceptable limits.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0834-2022·2022-05-11

    Losartan Potassium Tablets Recalled for Excessive Azido Impurity

    Macleods Pharma is recalling Losartan Potassium Tablets due to CGMP deviations with azido impurity levels exceeding acceptable limits. The recall affects 5.6 million tablets distributed nationwide.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0838-2022·2022-05-11

    Losartan Potassium tablets recalled for AZIDO impurity above limits

    Lupin Pharmaceuticals recalls Losartan Potassium tablets for CGMP deviations with AZIDO impurity above limits. The recall affects 657,336 bottles distributed nationwide; no illnesses reported.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2022·2022-05-11

    Evans Wedge Orthopedic Surgical Instrument Recalled for Parts Mixed During Rework

    restor3d Inc. is recalling 9 units of Evans Wedge Disposable Trials orthopedic surgical instruments because parts from different lots were mixed during a manufacturing rework and relabeling process.

    Product
    Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2022·2022-05-11

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Impurity

    Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg tablets nationwide due to AZIDO impurity levels above acceptable limits. Patients should consult their healthcare provider about their medication.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0211-2024·2022-05-04

    Suave Aerosol Antiperspirant Recalled for Potential Benzene Contamination

    Unilever is recalling all lots of Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent nationwide due to potential benzene contamination at the manufacturing facility.

    Product
    Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2022·2022-05-04

    IV Start Kit Convenience Kits Recalled for Inadequate Test Method Validation

    ROi CPS LLC is recalling 1,501 convenience kits containing regard IV Start Kits due to inadequate validation of manufacturing test methods. Products were distributed in Missouri.

    Product
    Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0811-2022·2022-05-04

    Compounded Injection Medication Recalled Due to Manufacturing Monitoring Deficiencies

    Olympia Compounding Pharmacy recalls 1,679 vials of QM-3 injection medication nationwide due to failures in environmental and personnel monitoring during manufacturing.

    Product
    QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0019-10.
    Category
    Drug
    Distribution
    Distributed nationwide