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.

101–125 of 216

  • HighFDA (Devices)·Z-1174-2024·2024-02-28

    Aquabiliti saline flush syringes recalled for potential sodium chloride content deficiency

    MRP, LLC is recalling AQUABILITI AQUASTAT saline flush syringes because they may fail to meet USP standards for sodium chloride content after 12 months.

    Product
    AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2024·2024-01-24

    FDA Recalls Vasostrict Injection for Exceeding Potency Specifications

    Par Sterile Products recalled Vasostrict (vasopressin) injection because stability testing showed the drug exceeded its upper potency specification limit. The recall involves 1,721 cartons distributed nationwide.

    Product
    VASOSTRICT — VASOSTRICT (VASOPRESSIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0122-2024·2023-12-06

    Paroxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity

    Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0312-2024·2023-11-22

    Medline Recalls Central Line Blood Culture Kits Over Expired Components

    Medline Industries is recalling 1,600 Central Line Blood Culture kits due to component expiration prior to the listed kit expiration date. Expired materials could compromise blood culture test accuracy.

    Product
    CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2024·2023-10-11

    Oxybutynin Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Zydus Pharmaceuticals recalls Oxybutynin Chloride Extended-Release Tablets 10 mg nationwide because the medication failed dissolution specifications. Affected lot numbers: M300652 and M300651.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1493-2023·2023-09-13

    Parent's Choice and Tippy Toes Sensitivity Infant Formula Recalled

    PBM Nutritionals recalls Parent's Choice and Tippy Toes Sensitivity Premium Infant Formula due to inadvertent market release of product that had been rejected. Affected batches were distributed across multiple states.

    Product
    Parent's Choice brand Sensitivity Premium Infant Formula, 638g, packaged in plastic tubs; and Tippy Toes brand Sensitivity Premium Infant Formula, 942g, packaged in composite cans
    Category
    Food
    Distribution
    23 states
  • HighFDA (Drugs)·D-0574-2023·2023-05-24

    Lorazepam injection vials recalled for elevated impurities and degradation

    Hikma Pharmaceuticals is recalling 1,352,475 vials of Lorazepam Injection due to failed quality tests showing elevated degradation compounds. Affected lots were distributed nationwide and in Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2023·2023-03-08

    Prescription Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations

    Accord Healthcare is recalling 44,068 bottles of Doxazosin 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations found during an FDA inspection.

    Product
    DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0170-2023·2023-02-01

    Metoprolol Succinate Tablets Recalled for Failed Dissolution Specification

    Ascend Laboratories is recalling 6,336 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide and in Puerto Rico, due to failed dissolution specification.

    Product
    METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0037-2023·2022-10-19

    G-PREPROTEIN Liquid Dietary Supplement Recalled for Quality and Appearance Issues

    Novis PR, LLC recalled G-PREPROTEIN Liquid Dietary Supplement due to atypical bottle appearance, unusual odor, and atypical bubbles when opened. The recall affects 1,369 units distributed in Puerto Rico.

    Product
    G-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net Contents 16 fl oz (473 mL), Kramer Novis
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0004-2023·2022-10-05

    Esomeprazole Magnesium Capsules Recalled for Out-of-Specification Potency

    Sun Pharmaceutical is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg nationwide due to superpotency findings. Lot AC14299 (expiration 12/2022) tested out of specification for drug assay at the 12-month stability timepoint.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0577-2022·2022-03-02

    Bortezomib 3.5 mg Vials Recalled Due to Failed Stability Specifications

    Dr. Reddy's Laboratories is recalling Bortezomib 3.5 mg single-dose vials nationwide due to failed stability specifications. Approximately 2,980 vials of lot H210233 (expiration 3/1/2023) are affected.

    Product
    Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0575-2022·2022-03-02

    Dr. Reddy's Azacitidine Injectable Drug Recalled for Failed Stability

    Dr. Reddy's Laboratories is recalling Azacitidine 100mg injectable vials nationwide due to failed stability specifications. Multiple lot numbers distributed across the United States are affected.

    Product
    AZACITIDINE — AZACITIDINE (AZACITIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0381-2022·2022-01-26

    Fexofenadine/Pseudoephedrine tablets recalled for failed dissolution

    Dr. Reddy's Laboratories is recalling Kroger Allergy Relief-D tablets (fexofenadine HCl 60mg/pseudoephedrine HCl 120mg) due to failed dissolution specifications. Approximately 11,064 boxes distributed nationwide are affected.

    Product
    FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2022·2021-12-22

    Medline Venous Access Pack-LF Recalled for Expired Saline Component

    Medline is recalling Venous Access Pack-LF Convenience Kits because the included saline solution component expired before the kit's labeled expiration date, creating a quality and safety issue.

    Product
    Venous Access Pack-LF Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0277-2022·2021-12-15

    Apollo Care VANComycin Injection Recalled for Crystallization

    Apollo Care is recalling VANComycin 1g in 0.9% Sodium Chloride injection due to crystallization that makes the product appear turbid. The affected lot was distributed in Missouri.

    Product
    VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0250-2022·2021-11-24

    REGARD Basic Cataract Tray Recalled for Out-of-Specification Component

    ROi CPS LLC is recalling 126 REGARD Basic Cataract trays because a Povidone-Iodine swabstick component is out of specifications. Affected trays were distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Basic Cataract tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0253-2022·2021-11-24

    REGARD Newborn Tray Recalled Due to Out-of-Spec Antiseptic Component

    ROi CPS LLC is recalling REGARD Newborn Trays (lot 86453F) distributed in FL, LA, and MO because some units contain a povidone-iodine swabstick component manufactured out of specifications.

    Product
    REGARD Newborn Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0008-2022·2021-10-06

    RC Cola 12 oz cans recalled for off flavor and aroma

    Keurig Dr Pepper is recalling RC Cola 12 oz aluminum cans (12-pack) due to consumer complaints of off flavor and aroma. The affected product was distributed to multiple states.

    Product
    Rc Cola 12 Oz (355 mL) packaged in an aluminum can 12 can to a pack
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0885-2021·2021-10-06

    ZTE-1034 Formula Antimicrobial Bowel homeopathic medicine recall

    Washington Homeopathic Products, Inc. is recalling ZTE-1034 Formula Antimicrobial Bowel (1000ml bottles) due to out-of-specification test results in identification testing. The product was distributed nationwide.

    Product
    ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum Album 10X, Baptisia Tinctoria 10X, Pulsatilla 10X, Lachesis Mutus 11X, Rhus Toxicodendron 10X, Belladonna 7X, Colchicum Autumnale 5X, Aconitum Napellus 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2487-2021·2021-09-29

    SARS-CoV-2 Process Control Swab Recalled Due to Plasmid DNA Contamination

    Microbiologics Inc is recalling its SARS-CoV-2 Process Control (Swab) because certain lot numbers were contaminated with plasmid DNA containing SARS-CoV-2 sequences. The affected product was distributed in the United States and internationally.

    Product
    SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0807-2021·2021-09-29

    Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications

    The Harvard Drug Group is recalling Carbamazepine 200mg tablets (Lot R01562, expiring 10/2022) distributed in North Carolina because they failed to meet required dissolution specifications, which may affect the drug's effectiveness.

    Product
    CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0772-2021·2021-09-01

    Atovaquone Oral Suspension Recalled for Temperature Abuse

    KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.

    Product
    ATOVAQUONE ORAL SUSPENSION — ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE)
    Category
    Drug
    Distribution
    Distributed nationwide