Hazard

Sterility recalls

2,383 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,383
Critical: 1
Severe: 2,113
Most recent: 2026-08-26

Of the 2,383 sterility recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,113 (89%) 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 sterility 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.

951–975 of 2383

ModerateFDA (Devices)·Z-1080-2017·2017-02-01
Atrium Medical Recalls Dual Chamber Ocean Drains Due to Sterility Issues
Atrium Medical is recalling Dual Chamber Ocean Drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.
Product
Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Patient Tubes) 2020-100 Ocean dual chamber with in-line connectors and no suction control stopcock (2 Patient Tubes) 2020-300 Ocean dual chambe
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1082-2017·2017-02-01
Atrium Medical Recalls Ocean Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Ocean Blood Recovery Drains because the outer packaging is not sterile. The recall affects units worldwide with expiration dates prior to October 2019.
Product
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain w
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1086-2017·2017-02-01
Atrium Medical Recalls Oasis Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Oasis Blood Recovery Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Product
Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1088-2017·2017-02-01
Atrium Medical Express Mini 500 Dry Seal Drain Recall
Atrium Medical is recalling Express Mini 500 dry seal drains because the outer packaging is not sterile.
Product
Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1023-2017·2017-01-25
Medacta M.U.S.T. Rods Recalled for Damaged Packaging and Sterility Issues
Medacta USA Inc. is recalling 82 M.U.S.T. Rods due to damaged packaging and lack of sterility assurance. The recall covers units distributed in the US and several international countries.
Product
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0315-2017·2017-01-11
Tri-Coast Pharmacy Recalls TriMix Injections Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 141 vials of TriMix compounded injections nationwide due to a lack of assurance of sterility.
Product
TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0415-2017·2017-01-11
Wells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the agency could not ensure the product was sterile. The recall covers vials prepared between February 2016 and September 2016.
Product
Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0249-2017·2017-01-11
Tri-Coast Pharmacy Recalls BCAA Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 265 vials of compounded BCAA solution because the agency cannot ensure the products are sterile.
Product
BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0295-2017·2017-01-11
Tri-Coast Pharmacy Recalls Slim Shot Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 127 vials of Slim Shot compounded between May and November 2016 due to a lack of assurance of sterility.
Product
Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1 mg/Pyridoxine HCL 2.2mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0277-2017·2017-01-11
Tri-Coast Pharmacy Recalls Mineral Mix Schrader Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 36 vials of Mineral Mix Schrader because the agency cannot assure the products are sterile. The recall covers products compounded between May and November 2016.
Product
Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric Sulf
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0279-2017·2017-01-11
Tri-Coast Pharmacy Recalls Pyridoxine HCL Due to Sterility Concerns
Tri-Coast Pharmacy is recalling compounded Pyridoxine HCL 100 mg/ml vials because there is a lack of assurance of sterility.
Product
Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0274-2017·2017-01-11
Tri-Coast Pharmacy Recalls Myers Cocktail #4 Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 66 vials of Myers Cocktail #4 compounded between May and November 2016 due to a lack of assurance of sterility.
Product
Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL), (10 ML). Compounded by Tri-Coast Pha
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0370-2017·2017-01-11
Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 933 vials of MIC/B-COMP/(M)/CHROM/CARN Injectable due to a lack of assurance of sterility.
Product
MIC/B-COMP/(M)/CHROM/CARN, 20 mg/40 mg/50 mg/25 mcg/25 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0407-2017·2017-01-11
FDA Recalls Tri 1 Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Tri 1 (PAP/PHEN/ATROPINE) NR Injectable vials because the product lacks assurance of sterility.
Product
Tri 1 (PAP/PHEN/ATROPINE) NR Injectable, 3.6 mg/0.4 mg/0.04 mg/mL, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0423-2017·2017-01-11
Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Sesame Oil Injectable vials because the product lacks assurance of sterility. The recall covers vials prepared between February 2016 and September 2016.
Product
Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0337-2017·2017-01-11
Wells Pharmacy Recalls Alprostadil Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Alprostadil 20 mcg/mL Injectable vials due to a lack of assurance of sterility.
Product
Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0387-2017·2017-01-11
Wells Pharmacy Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy is recalling 330 Sermorelin Acetate 28 mg Injectable Kits nationwide due to a lack of assurance of sterility.
Product
Sermorelin Acetate 28 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0390-2017·2017-01-11
FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP Injectable Kits nationwide due to a lack of assurance of sterility.
Product
Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0411-2017·2017-01-11
Wells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Trimix with Atropine Injectable vials due to a lack of assurance of sterility. The recall covers products prepared between February 2016 and September 2016.
Product
Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0403-2017·2017-01-11
Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 203 vials of compounded Testosterone Cypionate/Anastrozole Injectable nationwide due to a lack of assurance of sterility.
Product
Testosterone Cypionate/Anastrozole Injectable, 200 mg/1 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0409-2017·2017-01-11
Wells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling specific lots of Trimix with Atropine Injectable because the agency could not ensure the product was sterile.
Product
Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0392-2017·2017-01-11
FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) Injectable Kits nationwide due to a lack of assurance of sterility.
Product
Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0356-2017·2017-01-11
Wells Pharmacy Recalls Fluorescein/Indocyanine Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 203 kits of compounded Fluorescein/Indocyanine Injectable Kits nationwide due to a lack of assurance of sterility.
Product
Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0329-2017·2017-01-11
Wells Pharmacy Recalls Testosterone Enanthate Injectable Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 1,250 vials of compounded Testosterone Enanthate Injectable nationwide due to a lack of assurance of sterility.
Product
Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0367-2017·2017-01-11
Wells Pharmacy Recalls Methylcobalamin Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Methylcobalamin Injectable kits due to a lack of assurance of sterility. The recall covers kits prepared between February 2016 and September 2016.
Product
Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by Wells Pharmacy, Ocala, FL
Category
Drug
Distribution
Distributed nationwide