Hazard
163 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 163 quality control failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (5%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all quality control failure 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.
American Contract Systems, Inc. recalls 274,400 COVID-19 test kits distributed in Minnesota due to off-site assembly by individuals who may not have been properly trained.
Busse Convenience kits containing swab/swabstick drug products are recalled due to uncertainty about whether test methods used to validate manufacturing were adequately validated. Distributed nationwide.
A medical lab reagent (ABX Pentra Calcium AS CP) was shipped at room temperature instead of refrigerated, causing probable quality control failure. Affected patients may experience diagnostic delays and require repeat testing.
Mylan Institutional is recalling Esomeprazole Magnesium Delayed-Release Capsules 40 mg due to failed impurity specifications found during stability testing, affecting 885 cartons nationwide.
Olympia Compounding Pharmacy is recalling 4,521 vials of Phenylephrine 1 mg/mL due to manufacturing quality control failures. Environmental and personnel monitoring procedures were not properly investigated prior to October 1, 2021.
Olympia Compounding Pharmacy recalls 6,431 vials of Hydroxocobalamin B12 injection nationwide due to manufacturing quality control failures. Environmental and personnel monitoring systems prior to October 2021 did not properly investigate deviations from acceptable limits.
Olympia Compounding Pharmacy is recalling 1,849 vials of RE-1, a compounded injectable medication, due to CGMP deviations in environmental and personnel monitoring. Monitoring excursions were not properly investigated prior to October 2021.
Olympia Pharmaceuticals is recalling approximately 18,060 vials of Sermorelin Acetate distributed nationwide due to manufacturing quality control deviations in which monitoring excursions were not properly investigated. Patients should contact their healthcare provider.
Olympia Compounding Pharmacy recalls Testosterone Cypionate vials nationwide due to deviations in manufacturing quality monitoring procedures prior to October 2021.
Olympia Compounding Pharmacy is recalling T-50 injectable medication nationwide due to manufacturing quality control failures. Environmental and personnel monitoring controls were not properly investigated prior to October 2021.
Microbiologics Inc is recalling an inactivated Mycoplasma genitalium reference material (Catalog # HE0070N, Lot HE0070-01-1) because the quality control process did not meet specification requirements.
Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.
Microbiologics has recalled KWIK-STIK quality control kits due to a specific lot failing to meet resistance specifications for Gentamicin Synergy. The affected bacterial strain showed unexpected susceptibility when it should have been resistant.
A quality control negative control material in GBS diagnostic testing sets is yielding false-positive results, causing laboratory test failures and operational disruptions.
Microbiologics Inc recalls KWIK-STIK AST-GP quality control materials that produce incorrect antibiotic susceptibility test results. Two lot numbers were distributed worldwide.
Microbiologics Inc is recalling KWIK-STIK quality control kits used by laboratories because certain lots return incorrect test results that could affect laboratory testing accuracy.
Lupin Pharmaceuticals is recalling Oxycodone Hydrochloride Tablets (5 mg) due to out-of-specification impurity test results detected during long-term stability testing. Affected units were distributed in New York and Ohio.
Beckman Coulter is recalling 1,433 units of a cholesterol reagent that may fail calibration and produce erroneous low test results. Affected units were distributed nationwide and internationally.
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.
Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.
BioCheck, Inc. is recalling 314 T4 EIA Kit units due to failed shelf-life standards that resulted in failed quality control tests. The kits were distributed to five U.S. states and three overseas countries.
Washington Homeopathic Products, Inc. is recalling Z-107 Formula Soft Tissue Healing due to out-of-specification test results from identification testing. The product was distributed nationwide.
Washington Homeopathic Products is recalling Aconitum Napellus Fear homeopathic pills in multiple potencies and package sizes (562 bottles, Lot #26198) distributed nationwide because test results showed out-of-specification identification results on HPTLC analysis.
Washington Homeopathic Products is recalling Aconitum Napellus 12X Fear homeopathic medicine due to out-of-specification test results from identification testing.
Stanbio Laboratory is recalling Synchron Beta-Hydroxybutyrate diagnostic reagent due to reagent deterioration causing quality control values to fall out of expected range.