The Recall Desk

Hazard

Quality Defect recalls

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

What the numbers show

Total
216
Critical
0
Severe
9
Most recent
2026-08-12

Of the 216 quality defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (4%) 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 quality 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.

126–150 of 216

  • ModerateFDA (Drugs)·D-0724-2021·2021-08-25

    Combipatch Transdermal System Recalled for Failed Stability Specifications

    Noven Pharmaceuticals is recalling Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day because certain lots failed stability specifications and tested out of specification for shear.

    Product
    COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2142-2021·2021-08-04

    ThermoScientific Oxoid Antimicrobial Susceptibility Discs Recalled for Out-of-Specification Performance

    Remel Inc. is recalling certain lots of ThermoScientific Oxoid Antimicrobial Susceptibility Discs because they were manufactured out of specification, potentially affecting laboratory test accuracy. The recall involves 327 units distributed nationwide and to Bermuda.

    Product
    ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0652-2021·2021-07-21

    Nifedipine Extended-Release Tablets Recall for Failed Dissolution

    The Harvard Drug Group is recalling Nifedipine Extended-Release Tablets 30 mg due to failed dissolution specification discovered during routine stability testing. The affected lots were distributed in Ohio and New Jersey.

    Product
    NIFEDIPINE — NIFEDIPINE (NIFEDIPINE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1417-2021·2021-04-21

    Vectornate Recalls MedSchenker Smart Transport Medium Due to Discoloration

    Vectornate USA Inc is recalling 130,000 MedSchenker Smart Transport Medium systems due to discoloration and turbidity caused by a longer monsoon season at the manufacturing facility.

    Product
    MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laborator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1166-2020·2020-08-26

    La Canasta Recalls My Nana's Tortilla Chips for Staleness

    La Canasta Mexican Food Products is recalling My Nana's Thick & Crunchy Tortilla Chips because they turn stale before the expiration date.

    Product
    My Nana's Thick & Crunchy Tortilla Chips, 12 oz. (340g) paper bag (12 bags per case), UPC 0-34392-10161-8.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1271-2020·2020-05-27

    Mylan Recalls Aloprim Injection Vials Due to Discoloration

    Mylan Institutional LLC is recalling 3,010 vials of Aloprim (allopurinol sodium) for Injection due to out-of-specification appearance and color results.

    Product
    ALOPRIM — ALOPRIM (ALLOPURINOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1714-2020·2020-04-22

    Greiner Bio-One Recalls VACUETTE Coagulation Tubes Due to Anticoagulant Inconsistency

    Greiner Bio-One is recalling VACUETTE 2mL 9NC Coagulation Tubes because the sodium citrate anticoagulant levels were inconsistent. The recall affects 1,000,800 units distributed nationwide.

    Product
    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1029-2020·2020-03-25

    Strides Pharma Recalls Potassium Chloride Tablets Due to Oversized Size

    Strides Pharma Science Limited is recalling specific lots of Potassium Chloride Extended-Release Tablets because oversized tablets were found.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1272-2020·2020-02-26

    Philips HeartStart AEDs Recalled for Quality Standards Defect

    Philips is recalling 96 HeartStart AEDs because their Printed Circuit Assemblies were not manufactured or repaired to quality standards.

    Product
    Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1335-2020·2020-02-26

    Ethicon Recalls Stratafix Spiral Sutures Due to Testing Failures

    Ethicon, Inc. is recalling 660 units of Stratafix Spiral PDS Plus Violet sutures because the product did not meet internal testing specifications.

    Product
    1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0464-2020·2020-01-15

    Wayfare Vanilla Pudding Recalled for Package Bloating and Off Flavors

    Wayfare Health Foods LLC is recalling Plant Based Vanilla Pudding due to consumer complaints about package bloating, sourness, and textural issues.

    Product
    Plant Based WayFare Vanilla Pudding Organic Dairy Free, Item #1221. Net wt. 4 oz. There are 4/4 oz. cups per pack with cardboard overwrap. UPC 845681000358.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0574-2020·2019-12-18

    AuroMedics Recalls Vancomycin Hydrochloride Vials Due to Discoloration

    AuroMedics Pharma LLC is recalling specific lots of Vancomycin Hydrochloride for Injection due to reports of discoloration after reconstitution.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2347-2019·2019-08-28

    Aniara Diagnostica Recalls ZYMUTEST HIA MonoStrip ELISA Kits

    Aniara Diagnostica LLC is recalling 46 units of ZYMUTEST HIA MonoStrip ELISA kits due to residual crystallization and out-of-range negative controls.

    Product
    ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2346-2019·2019-08-28

    Aniara ZYMUTEST HIA MonoStrip IgG ELISA kit recalled for quality issues

    Aniara Diagnostica LLC is recalling 51 units of the ZYMUTEST HIA MonoStrip IgG ELISA kit due to residual crystallization and out-of-range negative controls.

    Product
    ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Food)·F-1980-2019·2019-08-14

    Sunchy Malta Beverage Recalled for Failing Taste Specifications

    Sunshine Bottling Co. is recalling specific lots of Sunchy Malta beverage because the product did not meet taste specifications.

    Product
    Sunchy Malta Pasteurized Non-Alcoholic Cereal Beverage in 7oz bottles 4 or 6/pack
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1913-2019·2019-07-10

    Siemens ADVIA Chemistry Creatine Kinase Reagent Recalled for Absorbance Trend

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Creatine Kinase (CK_L) reagent due to a steady upward trend in blank absorbance.

    Product
    ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithi
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1742-2019·2019-06-12

    Bio-Rad Recalls MRSASelect In Vitro Diagnostic Plates Due to Abnormal Coloration

    Bio-Rad Laboratories is recalling 5,212 units of MRSASelect in vitro diagnostic plates due to abnormal agar coloration and non-characteristic colony growth.

    Product
    MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1275-2019·2019-05-08

    US Worldmeds Recalls Revonto Dantrolene Sodium Injection Due to Precipitate

    US Worldmeds LLC is recalling 6,456 vials of Revonto (dantrolene sodium for injection) because the reconstituted solution showed out-of-specification precipitate during stability testing.

    Product
    Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0382-2019·2018-11-14

    Randox Recalls Liquid Cardiac Control CQ5053 Due to Unacceptable Variation

    Randox Laboratories is recalling Liquid Cardiac Control CQ5053 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.

    Product
    Liquid Cardiac Control, CQ5053
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0380-2019·2018-11-14

    Randox Liquid Cardiac Control CQ5051 Recalled for Unacceptable Variation

    Randox Laboratories is recalling Liquid Cardiac Control CQ5051 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.

    Product
    Liquid Cardiac Control, CQ5051
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0381-2019·2018-11-14

    Randox Recalls Liquid Cardiac Control CQ5052 Due to Unacceptable Variation

    Randox Laboratories is recalling Liquid Cardiac Control CQ5052 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.

    Product
    Liquid Cardiac Control, CQ5052
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-1213-2018·2018-10-03

    Hetero Recalls Montelukast Sodium Tablets Due to Blue Specks

    Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because a pharmacist reported blue specks on the tablets.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0990-2018·2018-08-01

    Aidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues

    Aidarex Pharmaceuticals is recalling 11 bottles of Enalapril Maleate 2.5mg because out-of-specification degradation products were found during stability testing.

    Product
    Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
    Category
    Drug
    Distribution
    Distributed nationwide