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.

676–700 of 1434

  • 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
  • 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-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 (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
  • 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-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-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-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-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
  • 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-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
  • 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-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 (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 (Drugs)·D-0744-2022·2022-04-13

    Phenobarbital Sodium Injection recalled for manufacturing sterility defect

    Vitae Enim Vitae Scientific, Inc. is recalling Phenobarbital Sodium Injection nationwide due to deviations from Current Good Manufacturing Practices (CGMP) that raise concerns about product sterility.

    Product
    PHENOBARBITAL SODIUM — PHENOBARBITAL SODIUM (PHENOBARBITAL SODIUM)
    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
  • HighFDA (Devices)·Z-0878-2022·2022-04-13

    DeRoyal ST Neonatal Dressing Change Kit recalled for unvalidated manufacturing test methods

    DeRoyal Industries is recalling 400 DeRoyal ST Neonatal Dressing Change Kits due to uncertain validation of manufacturing test methods. The recall affects kits distributed to healthcare facilities in Florida, New Jersey, and Tennessee.

    Product
    DeRoyal ST Neonatal Dressing Change Kit, 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
  • 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 (Drugs)·D-0741-2022·2022-04-13

    Tetracaine Injection Recalled for Sterility Assurance Manufacturing Defect

    Tetracaine 1% Injectable is being recalled due to sterility assurance failures caused by manufacturing deviations that may compromise product sterility.

    Product
    TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0737-2022·2022-04-06

    Lansoprazole Capsules Recalled for Failed Dissolution in Stability Testing

    Dr. Reddy's Laboratories is recalling specific lots of Lansoprazole 15 mg delayed-release capsules nationwide because the capsules failed to dissolve properly during long-term stability testing, which could affect medication effectiveness.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0671-2022·2022-03-30

    Clobetasol Propionate Cream USP 0.05% Recall for cGMP Deviations

    Teligent Pharma is recalling all unexpired Clobetasol Propionate Cream USP 0.05% nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the firm's stability study program.

    Product
    Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2022·2022-03-23

    Syphilis Test Reagent Pack Recalled for Vaccine Interference and Manufacturing Defects

    Bio-Rad's BioPlex 2200 Syphilis Test Reagent Pack is being recalled due to concerns that COVID-19 vaccines may interfere with test results, and due to manufacturing defects affecting reagent stability.

    Product
    BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide