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.

Which agencies issued them

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.

26–50 of 349

  • HighFDA (Drugs)·D-0498-2023·2023-04-12

    Drug recall: Atorvastatin 20 mg tablets due to manufacturing process deviations

    RemedyRepack Inc. is recalling 3,426 bottles of Atorvastatin 20 mg tablets nationwide due to Good Manufacturing Practice (cGMP) deviations. The recall was initiated voluntarily by the manufacturer.

    Product
    Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0513-2023·2023-04-12

    Clopidogrel Tablets 75 mg Recalled for Manufacturing Quality Deviations

    Preferred Pharmaceuticals is recalling Clopidogrel Tablets 75 mg nationwide due to manufacturing quality deviations found at manufacturer Accord Healthcare. The recall affects specific lot codes expiring October 2023.

    Product
    Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0429-2023·2023-03-08

    FDA Recalls Ropinirole 3mg Tablets due to CGMP Deviations

    Accord Healthcare's Ropinirole 3mg tablets are being recalled due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 14,928 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1167-2022·2022-06-08

    Busse Nerve Block Tray Swabs Recalled for Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.

    Product
    Nerve Block Tray Catalog Number: 3764R2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2022·2022-06-08

    Nerve Block Tray Recalled Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.

    Product
    Nerve Block Tray Catalog Number: 9342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0342-2022·2022-01-12

    MAJOR Fexofenadine Hydrochloride 60mg tablets recalled for failed impurity specifications

    Perrigo Company PLC is recalling MAJOR brand Fexofenadine Hydrochloride 12HR 60mg antihistamine tablets due to failed impurities and degradation specifications detected during stability testing.

    Product
    MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0362-2022·2021-12-22

    Bedside PICC CDS Convenience Kit Recalled for Expired Saline Component

    Medline Industries is recalling the Bedside PICC CDS Convenience Kit because a saline injection bag component expired in April 2020 while the kit's expiration date was later. No injuries have been reported.

    Product
    Bedside PICC CDS Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0466-2021·2021-06-02

    Cardinal Health Recalls Prilosec Due to Temperature Excursions

    Cardinal Health is recalling Prilosec (Omeprazole Magnesium) oral suspension packets due to intermittent temperature excursions during storage.

    Product
    PRILOSEC — PRILOSEC (OMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0424-2021·2021-06-02

    Cardinal Health Recalls Erythromycin Tablets Due to Temperature Excursions

    Cardinal Health is recalling Erythromycin Tablets 250mg due to intermittent temperature excursions during storage. The recall affects 135 cartons distributed in Florida, Georgia, and South Carolina.

    Product
    ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0301-2021·2021-03-24

    Akorn Recalls Gabapentin Oral Solution Due to Impurity Specifications

    Akorn, Inc. is recalling Gabapentin Oral Solution because it failed impurity specifications during stability testing. The product was distributed nationwide.

    Product
    Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0270-2021·2021-03-03

    Areva Pharmaceuticals Recalls Irinotecan Hydrochloride Injection Due to CGMP Deviations

    Areva Pharmaceuticals is recalling 3,287 vials of Irinotecan Hydrochloride Injection due to manufacturing quality deviations identified in a Warning Letter.

    Product
    Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, Inc., Gerogetown, IN 47122, Made in India, NDC 59923-714-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0148-2021·2020-12-23

    Biogen Recalls Vumerity Capsules Due to Dissolution Test Failures

    Biogen is recalling 5,307 bottles of Vumerity capsules because they failed dissolution testing. The medication may not release the drug as intended.

    Product
    VUMERITY — VUMERITY (DIROXIMEL FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0477-2021·2020-12-02

    Luminex Recalls Verigene Processor SP Due to Unapproved Test Fixtures

    Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate the devices.

    Product
    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0101-2021·2020-11-25

    Hikma Recalls Sodium Chloride Injection Vials Due to pH Failures

    Hikma Pharmaceuticals is recalling specific lots of Sodium Chloride Injection USP 0.9% 2 mL vials because they failed pH specifications.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0069-2021·2020-11-18

    Teva Recalls Mesalamine Tablets Due to Failed Dissolution Testing

    Teva Pharmaceuticals is recalling 133,829 bottles of Mesalamine Delayed-Release Tablets because stability testing revealed out-of-specification dissolution results.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0053-2021·2020-11-04

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly

    Boehringer Ingelheim is recalling specific lots of Catapres tablets because an extraneous peak was observed during dissolution testing.

    Product
    Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0052-2021·2020-11-04

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly

    Boehringer Ingelheim is recalling specific Catapres tablets because an extraneous peak was observed during dissolution testing. The recall covers products distributed nationwide and in Puerto Rico.

    Product
    Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0051-2021·2020-11-04

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly

    Boehringer Ingelheim is recalling Catapres tablets because an extraneous peak was observed during dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.

    Product
    Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0010-2021·2020-10-14

    Calvin Scott Recalls Diethylpropion Tablets Due to Missing Stability Studies

    Calvin Scott & Company is recalling specific lots of Diethylpropion 75 mg tablets because they were repackaged without supporting stability studies.

    Product
    Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-3041-2020·2020-10-07

    Ameditech Recalls Oratect III Oral Fluid Drug Screen Devices

    Ameditech Inc is voluntarily recalling 1,325 units of Oratect III Oral Fluid Drug Screen Devices due to a Class II safety concern.

    Product
    Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2753-2020·2020-08-12

    Randox Lipase Assay Substrate Recalled for Imprecision in Quality Control

    Randox Laboratories is recalling specific batches of Lipase R2 Substrate due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2751-2020·2020-08-12

    Randox Lipase Assay Reagent Recalled for Imprecision in Quality Control and Patient Samples

    Randox Laboratories is recalling specific batches of Lipase Colorimetric Reagent due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1419-2020·2020-08-05

    MasterPharm Recalls D-Biotin 300 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling D-Biotin 300 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1442-2020·2020-08-05

    MasterPharm Recalls Vardenafil Troches Due to Lack of Processing Controls

    MasterPharm LLC is recalling Vardenafil 20 mg Troches nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide