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.

601–625 of 1434

  • HighFDA (Drugs)·D-1162-2022·2022-07-06

    Losartan Potassium tablets recalled for elevated AZIDO impurity

    PD-Rx Pharmaceuticals recalled Losartan Potassium 50 mg tablets nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. The recall affects 687 bottles across multiple lots.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1163-2022·2022-07-06

    Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels

    PD-Rx Pharmaceuticals is recalling Losartan Potassium 100 mg tablets due to AZIDO impurity levels above acceptable limits detected during manufacturing. Approximately 1,320 bottles were distributed nationwide.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1155-2022·2022-06-29

    Clonazepam Tablets Recalled Due to Manufacturing Defect

    Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets (0.125mg) due to manufacturing defects where oversized tablets were found. The affected lot (MHC1430A, exp. 09/2023) was distributed nationwide.

    Product
    Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1152-2022·2022-06-29

    FDA Recalls Clonidine Transdermal Patches for Delivery System Defect

    Mayne Pharma is recalling 1,440 cartons of Clonidine transdermal patches nationwide due to an out-of-specification defect in the release liner that could affect proper drug delivery.

    Product
    CLONIDINE — CLONIDINE (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1211-2022·2022-06-22

    Drager SafeStar 55 Medical Devices Recalled for Possible Filter Occlusion

    Draeger Medical is recalling approximately 35,950 Drager SafeStar 55 medical devices due to a manufacturing error that may cause occlusion of the device's filters, potentially preventing proper device function.

    Product
    Drager SafeStar 55, Catalog No. MP01790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1126-2022·2022-06-22

    Homeopathic drug Bacillinum Pulmo recalled for manufacturing deviations

    Washington Homeopathic Products recalled Bacillinum Pulmo homeopathic drug due to manufacturing practice deviations. The Class II recall, initiated in May 2022 and terminated in May 2023, affected nationwide distribution.

    Product
    Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1149-2022·2022-06-22

    Hand Sanitizer Recalled for Acetaldehyde and Acetal Above Limits

    Hand Sanitizer LLC is recalling Say Goodbye to Germs hand sanitizer bottles due to CGMP deviations. FDA testing found acetaldehyde and acetal levels above acceptable limits.

    Product
    HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1128-2022·2022-06-22

    Candida Parapsilosis homeopathic remedy recalled for manufacturing practice deviations

    Washington Homeopathic Products is recalling Candida Parapsilosis homeopathic remedies distributed nationwide due to manufacturing practice deviations. The recall affects 134 bottles under lot numbers 22315 and 26502.

    Product
    Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15C, 25C, 30C, 13X, 27X, 30X, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1074-2022·2022-06-15

    MethylPREDNISolone Acetate Injectable Suspension Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling MethylPREDNISolone Acetate Injectable Suspension due to cGMP deviations involving temperature abuse during manufacturing. Affected vials were distributed nationwide.

    Product
    MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), 5 mL multi-dose vials, Rx only, MFG: Teva Pharma USA, NDC 0703-0063-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1109-2022·2022-06-15

    Pilocarpine Ophthalmic Solution Recalled Due to Temperature Abuse During Manufacturing

    McKesson Medical-Surgical Inc. is recalling Pilocarpine HCL Ophthalmic Solution due to temperature abuse during manufacturing that may affect product stability. The product was distributed nationwide.

    Product
    Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1030-2022·2022-06-15

    Smiths Medical Spinal Tray Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical recalls Smiths Medical spinal trays due to manufacturing temperature deviations. Approximately 8 cases were distributed nationwide.

    Product
    Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer: Smiths Medical ASD, Inc., NJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1104-2022·2022-06-15

    Injectable Pantoprazole Sodium Recalled for Temperature Exposure During Manufacturing

    McKesson Medical-Surgical Inc. is recalling injectable Pantoprazole Sodium for Injection due to manufacturing deviations involving temperature abuse. The nationwide recall affects a 10-vial carton; no illnesses have been reported.

    Product
    Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1108-2022·2022-06-15

    Tropicamide Ophthalmic Solution recalled for temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Tropicamide Ophthalmic Solution, 1% USP, due to temperature control deviations during manufacturing. The recall affects 31 bottles distributed nationwide.

    Product
    Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131435502
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1035-2022·2022-06-15

    Ophthalmic Drug Isopto Atropine Recalled Due to Manufacturing Temperature Deviation

    McKesson Medical-Surgical is recalling 13 bottles of Isopto Atropine 1% ophthalmic solution due to temperature-abuse violations of manufacturing standards that may have affected product sterility.

    Product
    ISOPTO ATROPINE — ISOPTO ATROPINE (ATROPINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1051-2022·2022-06-15

    Glucagon Emergency Kit Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Glucagon Emergency Kits nationwide due to temperature abuse during manufacturing, which may affect drug efficacy. Patients should contact their healthcare provider.

    Product
    Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe, Rx only, MFG: Eli Lilly, NDC 0002-8031-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1111-2022·2022-06-15

    Sumatriptan Succinate tablets recalled due to manufacturing temperature deviations

    McKesson Medical-Surgical is recalling Sumatriptan Succinate 100 mg tablets due to temperature abuse during manufacturing that may affect quality. Consumers should consult their physician or pharmacist about whether they have an affected product.

    Product
    SUMATRIPTAN SUCCINATE — SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1088-2022·2022-06-15

    Levofloxacin 500 mg Tablets Recalled Due to Manufacturing Temperature Abuse

    Mckesson Medical-Surgical is recalling Levofloxacin 500 mg tablets nationwide due to temperature abuse during manufacturing that violated pharmaceutical quality standards.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1018-2022·2022-06-15

    Albuterol sulfate inhalation solution recalled for manufacturing temperature-abuse defect

    McKesson Medical-Surgical is recalling albuterol sulfate inhalation solution 0.021% (0.63 mg/3mL vials) distributed nationwide. The FDA Class II recall is due to cGMP deviations involving temperature abuse.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1076-2022·2022-06-15

    FDA Recalls Proair HFA Albuterol Inhalation Aerosol for Temperature Abuse

    The FDA recalled 56 units of Proair HFA (albuterol sulfate) inhalation aerosol due to temperature abuse during manufacturing. The affected products were distributed nationwide.

    Product
    Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 59310-579-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1117-2022·2022-06-15

    Cefazolin Sodium injection recalled due to temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling 26 cases of Cefazolin Sodium injection due to manufacturing deviations involving temperature abuse. The product was distributed nationwide.

    Product
    CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1016-2022·2022-06-15

    Firmagon Degarelix Injection Recalled for Temperature Abuse During Distribution

    McKesson Medical-Surgical is recalling 15 boxes of Firmagon degarelix injection due to temperature abuse during distribution. The temperature exposure may compromise the pharmaceutical's stability and safety.

    Product
    Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8403-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1059-2022·2022-06-15

    Prescription Antibiotic Tablets Recalled Due to Temperature Abuse

    McKesson Medical-Surgical is recalling Sulfamethoxazole and Trimethoprim Tablets (800mg/160mg) nationwide due to cGMP deviations caused by temperature abuse during manufacturing.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1017-2022·2022-06-15

    GlucaGen Glucagon Injection Recalled for Temperature Control Deviations

    GlucaGen (glucagon) injection vials are being recalled due to temperature abuse during manufacturing that may have compromised product stability. The 187 vials were distributed nationwide.

    Product
    GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, Manufactured for: Boehringer Mannheim, NDC 0597-0260-10
    Category
    Drug
    Distribution
    Distributed nationwide