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.

601–625 of 1441

  • HighFDA (Devices)·Z-1480-2022·2022-08-03

    Medtronic Cobalt Implantable Cardioverter Defibrillators Recalled for Cathode Component Defect

    Medtronic is recalling three Cobalt Implantable Cardioverter Defibrillators (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification. Affected patients should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1184-2022·2022-07-13

    Boric Acid Vaginal Suppositories Recalled Due to Manufacturing Control Defects

    Wedgewood Village Pharmacy is recalling Boric Acid 600 mg vaginal suppositories (Lot #000-03843532) nationwide due to insanitary manufacturing conditions and lack of processing controls detected during an FDA inspection. No illnesses have been reported.

    Product
    Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1186-2022·2022-07-13

    Estriol Vaginal Cream Recalled Due to Insanitary Manufacturing Conditions

    Wedgewood Village Pharmacy is recalling Estriol vaginal cream nationwide due to insanitary manufacturing conditions and lack of processing controls identified during an FDA inspection.

    Product
    Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1183-2022·2022-07-13

    Boric Acid 600 mg Capsules Recalled for Insanitary Manufacturing Conditions

    The FDA has recalled Boric Acid 600 mg capsules (Lot #000-03868160, Exp: 09/14/22) manufactured by Wedgewood Village Pharmacy due to insanitary conditions and lack of processing controls observed during FDA inspection. The recalled product was distributed nationwide.

    Product
    Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1176-2022·2022-07-13

    Testosterone Cypionate Injectable Drug Recalled for Manufacturing Deviations

    Sun Pharmaceutical is recalling 27 vials of Testosterone Cypionate Injection (200 mg/mL) due to manufacturing deviations caused by abnormal machinery appearance. The recall affects multiple lot numbers distributed nationwide.

    Product
    TESTOSTERONE CYPIONATE — TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2022·2022-07-06

    Orthopedic Plates Recalled Due to Incorrect Etching and Mislabeling

    One lot of DVR Anatomic distal radius orthopedic plates was incorrectly etched during manufacturing and may have been placed into kits labeled as a different plate model. The affected plates were distributed to healthcare facilities nationwide.

    Product
    DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-1034-2022·2022-06-15

    FDA Recalls BSS Sterile Irrigating Solution for Manufacturing Temperature Deviations

    McKesson Medical-Surgical is recalling BSS sterile irrigating solution nationwide due to cGMP deviations involving temperature abuse during manufacturing. The recall affects prescription-only ophthalmic solutions.

    Product
    BSS — BSS (BALANCED SALT SOLUTION)
    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-1115-2022·2022-06-15

    Prescription anesthetic Diprivan recalled for manufacturing temperature deviation

    McKesson is recalling Diprivan (Propofol) injection due to manufacturing temperature deviations that may affect drug stability. The FDA Class II recall involves 122 cartons distributed nationwide to medical settings.

    Product
    DIPRIVAN — DIPRIVAN (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1000-2022·2022-06-15

    Bupivacaine HCl Injection Recalled Due to Temperature Abuse Manufacturing Defect

    Bupivacaine HCl Injection multi-dose vials are being recalled due to temperature abuse during manufacturing. The product was distributed nationwide. Patients should consult their healthcare provider for alternative treatments.

    Product
    Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50
    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