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.

176–200 of 216

  • ModerateFDA (Drugs)·D-0852-2016·2016-05-18

    Baxter Recalls Brevibloc Injection Due to Yellow Discoloration

    Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection because the solution shows atypical yellow discoloration. The recall covers 11,630 units distributed nationwide.

    Product
    BREVIBLOC — BREVIBLOC (ESMOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1089-2016·2016-03-16

    CMP Industries Recalls Impak Acrylic Resin Liquid Due to Potential Rust

    CMP Industries is recalling Impak Acrylic Resin Liquid, Lot 103113, due to potential rust discovered during an FDA inspection.

    Product
    IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1739-2015·2015-09-23

    MYO-DEN Injection Recalled for Potential Sterility and Quality Issues

    The Compounding Pharmacy of America is recalling MYO-DEN Injection due to FDA inspection findings of GMP violations that may impact sterility and product quality.

    Product
    MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2265-2015·2015-08-05

    Ivoclar Vivadent Recalls IPS Empress Universal Glaze Spray Due to Coarse Particles

    Ivoclar Vivadent is recalling IPS Empress Universal Glaze Spray because complaints indicated coarse particles in the glazed surface of dental restorations.

    Product
    IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0975-2015·2015-05-13

    Wockhardt Recalls Captopril Tablets for Thickness Specification Failures

    Wockhardt USA is recalling specific lots of Captopril Tablets 12.5 mg because they failed to meet thickness specifications.

    Product
    Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2015·2015-05-06

    Biocare Medical Recalls CD99 In Vitro Diagnostic Reagent Lots

    Biocare Medical is recalling specific lots of CD99 in vitro diagnostic reagents because staining intensity has decreased over time, potentially affecting shelf life.

    Product
    CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1379-2015·2015-04-15

    TEM Systems Recalls ROTROL P Control Vials Due to Partial Filling

    TEM Systems Inc is recalling specific lots of ROTROL P Control vials because some were found to be partially filled.

    Product
    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0394-2015·2015-03-04

    Sun Pharma Recalls Ketorolac Ophthalmic Solution Due to Particulate Matter

    Sun Pharma Global Fze is recalling specific bottles of Ketorolac Tromethamine Ophthalmic Solution because the product contains particulate matter exceeding specification limits.

    Product
    Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1032-2015·2015-02-04

    Fresenius Kabi Recalls HEPFLUSH-10 Heparin Lock Flush Solution Due to pH Failure

    Fresenius Kabi is recalling HEPFLUSH-10 heparin lock flush solution because a specific lot failed pH specifications. The recall covers 69,725 units distributed nationwide.

    Product
    HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2178-2014·2014-08-20

    Agfa Healthcare Recalls Radiographic Film Due to Fogged Sheets

    Agfa Healthcare is recalling specific lots of radiographic film because some sheets are fogged, which may affect image quality.

    Product
    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1285-2014·2014-05-07

    Glytone Acne Facial Cleanser Recalled for Viscosity Specification Failure

    Genesis Pharmaceuticals is recalling 461 bottles of Glytone Acne Treatment Facial Cleanser due to out-of-specification viscosity results.

    Product
    Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1286-2014·2014-05-07

    Aaron Industries Recalls Tussin DM Cough Syrup Due to Precipitate

    Aaron Industries is recalling 108,792 bottles of Tussin DM cough syrup because a white substance, identified as the active ingredient Guaifenesin, was observed in some bottles.

    Product
    Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, La
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1238-2014·2014-04-30

    GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1242-2014·2014-04-30

    Nicorette Lozenges Recalled for Thickness and Potency Failures

    GlaxoSmithKline is recalling Nicorette 2 mg lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1870-2014·2014-04-23

    Gold Medal Cherry Glaze Popcorn Flavoring Recalled for High Concentration

    Gold Medal Products is recalling 2521 Cherry Glaze Pop popcorn flavoring because the flavor concentration is too high. The product was distributed in 17 states.

    Product
    2521 Cherry Glaze Pop (Flavoring for popcorn) - Paperboard Carton
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0792-2014·2014-01-29

    Remel Recalls Oxoid Cefpodoxime Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling Oxoid Cefpodoxime 10 mcg. Antimicrobial Susceptibility Test Discs because some cartridges may contain discs not impregnated with antibiotic.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0795-2014·2014-01-29

    Remel Recalls Oxoid Ertapenem Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling Oxoid Ertapenem 10 mcg. Antimicrobial Susceptibility Test Discs because some cartridges may contain discs not impregnated with antibiotic.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0535-2014·2013-12-25

    3M ESPE Imprint II and Paradigm Impression Materials Recalled for Quality Issues

    3M is recalling specific lots of Imprint II and Paradigm dental impression materials because a defect reduces moisture displacement, potentially affecting impression quality.

    Product
    3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression mater
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0378-2014·2013-12-04

    Mizuho Sugita Titanium Aneurysm Clips Recalled for Discoloration

    Mizuho America is recalling 35 units of Sugita Titanium Standard Aneurysm Clip II, Temporary Mini Type No 58 due to discoloration in specific lots.

    Product
    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-002-2014·2013-11-27

    Boehringer Ingelheim Recalls Oxcarbazepine Oral Suspension Due to Resuspension Issues

    Boehringer Ingelheim is recalling 10,267 bottles of Oxcarbazepine Oral Suspension because the product failed to meet resuspendability requirements.

    Product
    Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2013·2013-07-31

    Becton Dickinson Recalls BCYE Selective Agar Plates Due to Reduced Vancomycin

    Becton Dickinson is recalling 163 cartons of BCYE Selective Agar with PAV because the media may exhibit reduced levels of Vancomycin.

    Product
    BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isol
    Category
    Medical Device
    Distribution
    Distributed nationwide