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.
The Compounding Pharmacy of America is recalling Hydromorphone 70 mg/ml Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
The Compounding Pharmacy of America is recalling Testosterone 200 mg sterile pellets due to GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling MEGA-BURN Injection due to FDA inspection findings of GMP violations that may impact sterility.
The Compounding Pharmacy of America is recalling Testosterone 100 mg sterile pellets nationwide because FDA inspections found GMP violations affecting sterility.
The Compounding Pharmacy of America is recalling Clotrimazole 2% Otic Suspension due to FDA inspection findings of GMP violations that may impact sterility.
PharMEDium Services is recalling 120 cassettes of Ropivacaine HCl 0.2% due to a reported sterility failure. The affected units were distributed to Virginia, Illinois, Pennsylvania, and Idaho.
Customed, Inc. is recalling 507 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 1,128 angiography packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 96 OB Packs CS/4 in Puerto Rico due to inadequate sterilization validation and package integrity.
Customed, Inc. is recalling 1,050 units of Dressing Change kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 5,500 urethral catheter trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Arthroscopy Packs due to inadequate validation of sterilization processes and package integrity for products released as sterile.
Customed, Inc. is recalling 525 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 160 units of Foley Catheter Kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/2/20 Injection in Oklahoma due to a lack of documentation proving proper environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 20 mcg/mL Injection due to a lack of documentation ensuring proper environmental monitoring during production.
Lincare, Inc. is recalling Fluorouracil 1200mg IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling Fluorouracil IV bags compounded by United Medical IV Center because the sterility of the product is not assured.
Lincare, Inc. is recalling TPN 3:1 bags compounded between May 14 and May 27, 2015, because the sterility of the product is not assured.
Lincare, Inc. is recalling specific Fluorouracil IV bags because the sterility of the product is not assured.
Lincare, Inc. is recalling Gentamicin 14.4 mg syringes because the sterility of the product is not assured. The recall affects 2 syringes distributed in Arkansas.
Gyrus Acmi is recalling Diego Elite Tubesets due to a potential lack of sterility assurance. The recall affects 12,020 boxes distributed in the US, Canada, and other countries.
Gyrus Acmi is recalling 22,250 boxes of Diego Elite Tubesets due to a potential lack of sterility assurance. The devices are used for ENT and head and neck procedures.
Fallon Wellness Pharmacy is recalling 56 vials of Methylcobolamin injections in New York due to a lack of assurance of sterility.
Health Innovations Pharmacy is recalling Boric Acid Vaginal Capsules due to quality control issues affecting sterility and stability data.