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.

676–700 of 1441

  • 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
  • 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 (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
  • 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-0812-2022·2022-05-04

    QM-4 Compounded Injectable Recalled for Manufacturing Control Deviations

    Olympia Compounding Pharmacy is recalling QM-4, a compounded injectable, for manufacturing control deviations. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021.

    Product
    QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 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 73198-0020-10.
    Category
    Drug
    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
  • 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-0805-2022·2022-05-04

    Compounded injectable drug recall due to manufacturing quality control deviations

    Olympia Compounding Pharmacy is recalling T-101, an injectable medication distributed nationwide, due to manufacturing quality control deviations in environmental and personnel monitoring prior to October 2021.

    Product
    T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
    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 (Drugs)·D-0822-2022·2022-05-04

    Phenylephrine Injectable Recalled Due to Manufacturing Quality Control Deviations

    Olympia Compounding Pharmacy is recalling 4,521 vials of Phenylephrine 1 mg/mL due to manufacturing quality control failures. Environmental and personnel monitoring procedures were not properly investigated prior to October 1, 2021.

    Product
    Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0809-2022·2022-05-04

    Prescription Injectable ST-1 Recalled for Manufacturing Process Control Failures

    Olympia Compounding Pharmacy is recalling 525 vials of ST-1, a prescription injectable medication, due to manufacturing control failures.

    Product
    ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0011-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2022·2022-05-04

    Testosterone Cypionate Recalled Due to Manufacturing Quality Control Deviations

    Olympia Compounding Pharmacy is recalling Testosterone Cypionate 200 mg/mL due to failure to properly investigate manufacturing process monitoring deviations that occurred before October 2021. The recall affects 7,161 vials distributed nationwide.

    Product
    Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0054-10; b) 5 mL Multi-Dose vial, NDC 73198-0054-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0817-2022·2022-05-04

    PGE-1 Alprostadil Injection Recalled for Manufacturing Process Deviations

    Olympia Compounding Pharmacy is recalling 821 vials of PGE-1 Alprostadil 40 mcg/mL injection nationwide. The recall is due to Current Good Manufacturing Practice deviations in environmental and personnel monitoring procedures that were not properly investigated.

    Product
    PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0820-2022·2022-05-04

    Olympia Compounding Pharmacy recalls T-50 injectable medication for manufacturing quality control deviations

    Olympia Compounding Pharmacy is recalling T-50 injectable medication nationwide due to manufacturing quality control failures. Environmental and personnel monitoring controls were not properly investigated prior to October 2021.

    Product
    T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0778-2022·2022-04-27

    Injectable Drug Recalled Due to Sterility Assurance Concerns

    North American Custom Laboratories is recalling LL-37 2 mg/mL injectable vials due to manufacturing process deviations that raise questions about product sterility. The company distributed 25 vials nationwide.

    Product
    LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0779-2022·2022-04-27

    Melanotan II Injectable Recalled for Manufacturing Sterility Defect

    Melanotan II injection (35 vials) is being recalled nationwide due to manufacturing deviations that could compromise product sterility. Patients should not use affected lots and should contact their healthcare provider.

    Product
    Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0775-2022·2022-04-27

    Injectable Drug Recall: ARA-290 Due to Sterility Manufacturing Defects

    ARA-290 (Cibinetide Acetate) injection is recalled due to manufacturing deviations that call sterility into question. Patients should contact their healthcare provider, as 28 vials have been distributed nationwide.

    Product
    ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0780-2022·2022-04-27

    PT-141 Injection Recalled for Sterility Assurance Defect

    PT-141 (Bremelanotide) injection vials are recalled due to manufacturing deviations that compromise sterility assurance. The FDA Class II recall involves 43 vials distributed nationwide.

    Product
    PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0777-2022·2022-04-27

    Ipamorelin and Sermorelin Injectable Medications Recalled Due to Sterility Deviations

    North American Custom Laboratories is recalling 189 vials of Ipamorelin/Sermorelin injectable due to manufacturing deviations that call into question the sterility of this prescription medication.

    Product
    Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0776-2022·2022-04-27

    Injectable Drug Recalled for Sterility Concerns Due to Manufacturing Defects

    North American Custom Laboratories recalls BPC-157 injectable solution due to manufacturing deviations that compromise sterility assurance. The FDA classified this as a Class II recall affecting 778 vials distributed nationwide.

    Product
    BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2022·2022-04-27

    Abbott TactiCath Ablation Catheter Disabled by Preprogrammed First-Use Date

    Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2022·2022-04-20

    Orthopedic surgical driver oversized, affecting hammertoe correction

    Nextremity Solutions is recalling the Nextra Hammertoe Correction System Driver (SKU: NX-DR) due to oversizing at the proximal end, which impairs connection and removal from the implant, causing surgical delays. The defect affects 239 units distributed in the US, Japan, and the Netherlands.

    Product
    Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2022·2022-04-20

    Hammertoe Correction Surgical System Recalled for Driver Connection Defect

    Nextremity Solutions recalls the Nextra Hammertoe Correction System because the driver's proximal end is oversized, making it difficult to connect and remove from the implant, potentially delaying surgery.

    Product
    Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0759-2022·2022-04-13

    Pfizer Recalls Blood Pressure Tablets Due to Manufacturing Defects

    Pfizer is recalling quinapril HCl/hydrochlorothiazide tablets due to manufacturing defects that allowed N-nitroso impurities to exceed acceptable daily intake limits. Patients taking affected lots should contact their pharmacy.

    Product
    quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2022·2022-04-13

    DeRoyal DEXMED Access Center Tray Recalled for Manufacturing Test Validation Uncertainty

    DeRoyal Industries is recalling 1,360 DEXMED ACCESS CENTER TRAY kits with Prevantics antiseptic swabs due to uncertain validation of manufacturing test methods. The affected kits were distributed in Florida, New Jersey, and Tennessee.

    Product
    DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Medical Device
    Distribution
    3 states