The Recall Desk

Hazard

Quality Control recalls

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

What the numbers show

Total
349
Critical
0
Severe
124
Most recent
2026-09-02

Of the 349 quality control recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 124 (36%) 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 control 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.

1–25 of 349

  • ModerateFDA (Drugs)·D-0804-2026·2026-09-02

    Apotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing

    Apotex Corp. is recalling 6,972 bottles of Paxil CR 37.5mg tablets because the product failed dissolution specifications and 24-month stability testing.

    Product
    PAXIL — PAXIL (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2657-2026·2026-07-08

    DuoGlide Short-Term Dialysis Catheter recall due to deficient manufacturing

    Bard Access Systems is recalling lidocaine ampoules used with DuoGlide Short-Term Dialysis Catheters due to deficient manufacturing practices by the supplier. The catheters are used for temporary vascular access for hemodialysis.

    Product
    5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2460-2026·2026-06-24

    directCHECK whole blood control labeled with incorrect performance range

    directCHECK ACT-LR whole blood quality control, level 2, is being recalled because the assayed control carries labeling with an incorrect performance range. 6,060 units affected.

    Product
    directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2026·2026-02-11

    Amyloid plasma controls recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 179 units of Lumipulse beta-Amyloid Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and perso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2026·2026-02-11

    pTau 217 plasma controls recalled over falsely elevated ratio results

    Fujirebio Diagnostics is recalling 148 units of Lumipulse pTau 217 Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.

    Product
    Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2026·2025-12-31

    Campylobacter six-pack control kits recalled over failure to recover the organism

    Microbiologics is recalling 18 KWIK-STIK 6-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

    Product
    KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2026·2025-12-31

    Campylobacter control kits recalled because they may fail to recover the organism

    Microbiologics is recalling 86 KWIK-STIK 2-Pack units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

    Product
    KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2026·2025-12-31

    Campylobacter LYFO DISK controls recalled over failure to recover the organism

    Microbiologics is recalling LYFO DISK units for Campylobacter jejuni because affected units may fail to recover the target microorganism.

    Product
    LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0217-2026·2025-12-17

    Lanthanum carbonate tablets recalled in a second hardness specification failure

    Cipla USA is recalling 1,180 boxes of Lanthanum Carbonate chewable tablets, 1000mg, from a further lot after an out of specification hardness test result.

    Product
    LANTHANUM CARBONATE — LANTHANUM CARBONATE (LANTHANUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0220-2026·2025-12-17

    Ganirelix acetate injection recalled after failing an impurity specification

    Lupin Pharmaceuticals is recalling 32,736 units of Ganirelix Acetate Injection after out of specification results for the ganirelix acetate acrylic acid adduct impurity.

    Product
    GANIRELIX ACETATE — GANIRELIX ACETATE (GANIRELIX ACETATE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Food)·H-0214-2026·2025-12-10

    Fat free chocolate milk recalled over potential quality control issues

    Meadowgold Dairies Hawaii is recalling 75,566 half-pint cartons of Meadow Gold Hawaii's Dairy Fat Free Chocolate Milk over potential quality control issues.

    Product
    Meadow Gold Hawaii's Dairy Fat Free Chocolate Milk, Grade A Pasteurized Homogenized Vitamin A&D, half-pint carton. Product is perishable keep refrigerated. UPC 8 50019 06410 0. Ingredients: Nonfat Milk, Sugar Cane, Cocoa (processed with Alkali), Corn Starch, Carrageenan, Salt,
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0876-2026·2025-12-10

    Culture media quality control kits recalled over mislabeled lot numbers on pouches

    Microbiologics is recalling 5 KWIK-STIK quality control kits because some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

    Product
    KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2272-2025·2025-08-13

    epoc BUN test cards may show a negative sodium bias

    epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.

    Product
    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2238-2025·2025-08-13

    BD Trucount control kits carry incorrect standard deviation values for beads

    BD Trucount Controls 30 Test kits are being recalled because they contain incorrect standard deviation values for the low and high control beads, which compromises accurate bead count calculation. 629 kits affected.

    Product
    BD Trucount Controls, 30 Test - REF: 340335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2237-2025·2025-08-13

    BD Trucount 664343 control kits carry incorrect standard deviation values

    BD Trucount Controls 30 Test kits, REF 664343, are being recalled because they contain incorrect standard deviation values for the low and high control beads. 10 kits are affected.

    Product
    BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2195-2025·2025-08-06

    LYFO-DISK M. canis single packs may fail to recover the organism

    LYFO-DISK M. canis preparations, REF 0894L, are being recalled because they may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2194-2025·2025-08-06

    LYFO-DISK M. canis multipacks may fail to recover the organism

    LYFO-DISK M. canis preparations in 6-pack and 2-pack formats are being recalled because they may result in failure to recover the target microorganism. 32 units are affected.

    Product
    LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2124-2025·2025-07-23

    Culture media quality control kits contain the wrong bacterial organism

    KWIK-STIK and LYFO DISK quality control kits for culture media are being recalled because affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. 21 units affected.

    Product
    KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2087-2025·2025-07-09

    ADVIA hematology control lots carry incorrect platelet value assignments

    ADVIA 120/2120/2120i 3-in-1 TESTpoint Control lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 4,214 units affected.

    Product
    ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0529-2025·2025-07-09

    Pitavastatin Tablets Recalled for Failed Impurity and Degradation Specifications

    AvKARE is recalling Pitavastatin 2 mg tablets nationwide due to failed impurity and degradation specifications. The affected lots do not meet quality standards for chemical purity.

    Product
    PITAVASTATIN — PITAVASTATIN (PITAVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2024·2024-07-10

    FDA recalls Dream Cream topical product due to manufacturing quality violations

    Little Moon Essentials voluntarily recalls Dream Cream due to manufacturing quality control violations. No illnesses reported.

    Product
    Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0945-2023·2023-08-02

    SCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations

    SCA Pharmaceuticals is recalling 183 bags of a fentanyl-bupivacaine injectable due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed to Kentucky and New Jersey.

    Product
    FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
    Category
    Drug
    Distribution
    2 states