Hazard
1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) 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 sterility 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.
Pharm D Solutions is recalling Lipo MIC-12 Compound Injectable vials nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling 442 vials of HCG 6000 unit injectable nationwide due to a lack of assurance of sterility.
Ellex iScience is recalling 90 units of the iTRACK 250A Canaloplasty Microcatheter Kit because a sterility failure was found in one unit of the lot.
Auro Pharmacies is recalling 43 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure product sterility.
Auro Pharmacies, Inc. is recalling 90 vials of Methyl-Cobalamin injectable because inadequate processes and equipment were used to assure sterility.
Auro Pharmacies is recalling 11 vials of Testosterone Enanthate/Cypionate injectable because the manufacturer could not assure the sterility of the product.
Pharmcore Inc. is recalling 355 vials of Human Chorionic Gonadotropin 20000 IU due to a lack of assurance of sterility.
Pharmcore Inc. is recalling 3,070 vials of Human Chorionic Gonadotropin 2500 IU due to a lack of assurance of sterility. The recall is nationwide.
Auro Pharmacies is recalling 32 vials of Testosterone Cypionate/Enanthate injectable because inadequate processes and equipment failed to assure the sterility of the product.
Auro Pharmacies is recalling 167 vials of Calcium Gluconate injectable because processes and equipment were inadequate to assure sterility.
Ranier's Compounding Laboratory is recalling DMSO 6.25% Opth Sol due to a lack of assurance of sterility. The product was distributed within Pennsylvania.
Ranier's Compounding Laboratory is recalling Atropine 0.01% Opth Solution due to a lack of assurance of sterility. The product was distributed within Pennsylvania.
Avella of Deer Valley is recalling 130 bags of Morphine 1 mg/mL due to potential bag leakage and lack of assurance of sterility.
Avella of Deer Valley, Inc. is recalling 2,500 bags of ceFAZolin 2 gm in NS 100mL due to potential bag leakage that compromises sterility.
La Vita Compounding Pharmacy is recalling 191 vials of Glutathione 200mg/mL Injection because production methods raised questions about the sterility of the drug product.
Avella of Deer Valley is recalling 480 single-dose hydromorphone syringes due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley, Inc. is recalling 15 cassettes of fentanyl and bupivacaine due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley is recalling specific lots of ePHEDrine 50mg syringes because bags may leak, compromising sterility.
Coast Quality Pharmacy LLC is recalling 52 vials of Macroaggregated albumin (MAA) kits due to a lack of assurance of sterility. The affected products were distributed to six states.
Vitalab Pharmacy, Inc. is recalling a sterile injectable drug product because airflow patterns may not support aseptic production, raising sterility concerns.
AuroMedics Pharma LLC is recalling 308,112 bags of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of mold.
AuroMedics Pharma LLC is recalling Linezolid Injection bags due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.
AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.
Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter because the device may not be properly sterilized during reprocessing.
Cook Inc. is recalling 760 StoneBreaker Exhaust Lines because the interior may not be properly sterilized during reprocessing.