Hazard
1,434 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 1,434 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 107 (7%) 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 manufacturing 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.
CoolSeal Generator units (REF: CSL-200-50) may have a manufacturing defect preventing them from meeting electrical safety standards, potentially resulting in unintended energy delivery to patients.
K2M recalled 686 units of the Everest MI XT Inner Dilator due to a manufacturing nonconformance preventing proper fit with outer dilators during surgery. Two complaints prompted the recall.
Stryker is recalling MEDPOR Titan OFW implants after one unit was found with an incorrectly placed barrier layer. The defect resulted from manufacturing error rather than design.
Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
Nobel Biocare is recalling 702 NobelReplace dental implant components due to a manufacturing defect that prevents proper driver engagement. The defect could result in aborted or delayed surgical procedures.
Biomet is recalling a shoulder implant stem due to a manufacturing defect in the porous plasma coating. Internal testing indicated the coating may not have sufficient adhesion strength after an unvalidated waterjet rework process.
Perrigo Company is recalling Children's Pain and Fever (Acetaminophen) Oral Suspension distributed by Kroger nationwide due to manufacturing with a contaminated excipient. The product was made with an ingredient sourced from a supplier that had recalled that same excipient.
Perrigo Company PLC is recalling Signature Care Nasal Decongestant (Oxymetazoline HCl 0.05%) nationwide due to contamination from a recalled excipient used in manufacturing.
Perrigo Company is recalling Children's Pain and Fever (Acetaminophen) oral suspension due to use of contaminated excipient during manufacturing. The product was distributed nationwide in the United States.
Pharmasol Corporation is recalling Lung Cleaner (saline eucalyptus) inhalers in 37 oz cans due to current good manufacturing practice (cGMP) deviations identified during production.
Professional Disposables International is recalling Prevantics Swabstick (chlorhexidine gluconate and isopropyl alcohol) products nationwide due to uncertain validation of the test methods used during manufacturing.
ANI Pharmaceuticals is recalling Alprazolam Tablets, USP 2.0 mg nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 70,788 bottles distributed throughout the United States.
ANI Pharmaceuticals, Inc. has recalled Pyrazinamide Tablets USP 500 mg due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5,477 bottles distributed nationwide.
Avanos Medical is recalling the MIC Percutaneous Endoscopic Gastrostomy (PEG) Kit because the external retention bolster may be oversized relative to the tube. Approximately 2,652 units have been distributed in the US, Canada, and Chile.
ULTRAtab Laboratories is voluntarily recalling approximately 955,928 melatonin ER 0.5 mg caplets due to deviations from FDA manufacturing standards. Bulk product distributed to New York and Florida distributors in 2021.
ULTRAtab Laboratories is recalling approximately 14.3 million tablets of APAP 500 mg Phenyl HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
ULTRAtab Laboratories is recalling approximately 3.7 million acetaminophen 325 mg tablets due to Good Manufacturing Practice (CGMP) deviations discovered in the manufacturing process.
ULTRAtab Laboratories is recalling 4-Component Cold Tabs in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed to three distributors.
ULTRAtab Laboratories, Inc. is voluntarily recalling 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) in bulk container form due to Current Good Manufacturing Practice (CGMP) deviations.
ULTRAtab Laboratories is recalling Spearmint Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to manufacturing process deviations. The recall affects approximately 1.5 million tablets distributed to three distributors.
ULTRAtab Laboratories is recalling Coated APAP 325mg acetaminophen tablets sold in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects approximately 16.4 million tablets distributed to three wholesalers.
ULTRAtab Laboratories is voluntarily recalling Normed APAP 325 mg acetaminophen bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 3.7 million tablets distributed to three distributors.
ULTRAtab Laboratories is recalling approximately 451,123 APAP 325 mg/Phenylephrine HCl 5 mg tablets in bulk containers due to CGMP deviations. The product was distributed to three distributors for further distribution as finished goods.
ULTRAtab Laboratories is recalling Trial Antacid Tablet bulk containers (Calcium Carbonate 420 mg) due to CGMP deviations. The product was distributed to three distributors who may have distributed finished product.
ULTRAtab Laboratories is recalling HPC Tablet (a combination of acetaminophen, aspirin, caffeine, and salicylamide) due to manufacturing deviations. The recall affects approximately 50 million tablets distributed in bulk to three distributors.