Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 3,438
Critical: 25
Severe: 993
Most recent: 2026-10-14

Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) 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 infection risk 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.

876–900 of 3438

SevereFDA (Drugs)·D-0413-2022·2022-02-02
Phenol Injection Solution Recall Due to Lack of Sterility Assurance
Edge Pharma, LLC is recalling Phenol Sterile Solution for Injection (6%, 5 mL vials) nationwide due to lack of assurance of sterility. The recall affects 309 vials distributed under specific lot codes.
Product
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0411-2022·2022-02-02
Neostigmine Methylsulfate Injectable Syringes Recalled for Sterility Assurance
Edge Pharma, LLC is recalling Neostigmine methylsulfate 5 mg/5mL single-use syringes for IV or IM injection due to lack of assurance of sterility. Approximately 160 syringes nationwide may be affected.
Product
Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0407-2022·2022-02-02
Mitomycin-C Injectable Syringes Recalled for Sterility Assurance Failure
Edge Pharma is recalling Mitomycin-C 40 mg/40 mL single-dose syringes (NDC 05446-1416-01) nationwide due to lack of assurance of sterility. Approximately 860 syringes are affected.
Product
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0404-2022·2022-02-02
Lidocaine HCL / Bupivacaine HCL Sterile Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma is recalling a sterile ophthalmic injectable solution because the manufacturer cannot guarantee that the product remains sterile. The recall affects approximately 1,202 syringes distributed nationwide.
Product
Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0427-2022·2022-02-02
Vancomycin HCl IV Injection Recalled Due to Sterility Assurance Concerns
Edge Pharma is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects approximately 749 bags distributed nationwide.
Product
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0421-2022·2022-02-02
Sterile Ophthalmic Solution Lacks Assurance of Sterility
Edge Pharma is recalling a sterile ophthalmic solution due to lack of assurance of sterility. The recall affects 2,562 syringes distributed nationwide.
Product
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0420-2022·2022-02-02
Edge Pharma Phenylephrine/Tropicamide Ophthalmic Solution Sterility Recall
Edge Pharma is recalling a sterile ophthalmic solution (Phenylephrine HCl/Tropicamide 2.5%/1%) because the manufacturer cannot assure sterility of the product. The recall affects 363 droptainers distributed nationwide.
Product
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2022·2022-02-02
Methotrexate Injection Recalled Due to Lack of Sterility Assurance
Edge Pharma, LLC is recalling Methotrexate, USP, Sterile Solution for Injection (125 mg/5mL) due to lack of assurance of sterility. The recall affects 457 syringes distributed nationwide.
Product
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0423-2022·2022-02-02
Betadine Sterile Ophthalmic Solution Recalled for Sterility Assurance
Edge Pharma is recalling Betadine sterile ophthalmic solution syringes due to lack of assurance of sterility. The affected product is a preservative-free, single-use ophthalmic solution distributed nationwide.
Product
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0403-2022·2022-02-02
Gemcitabine Intravesical Solution Recalled for Lack of Sterility Assurance
Edge Pharma is recalling approximately 627 syringes of Gemcitabine Sterile Intravesical Solution nationwide because the manufacturer cannot guarantee the product is sterile. The recalled batches were distributed between December 2021 and February 2022.
Product
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0369-2022·2022-01-19
Exela Sodium Bicarbonate Injection Recalled for Sterility Assurance Failure
Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The affected lot (C0001088/P0001317, expiring 08/2023) was distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0370-2022·2022-01-19
Methylprednisolone Acetate Injectable Suspension Lacks Sterility Assurance
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension 400 mg/10mL due to lack of assurance of sterility. The recall affects one lot distributed to facilities in Tennessee, Mississippi, and Ohio.
Product
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0323-2022·2022-01-05
SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance
SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.
Product
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0315-2022·2022-01-05
dilTIAZem HCl in Dextrose Injection Recalled for Sterility Assurance
SterRx is recalling dilTIAZem HCl in 5% Dextrose Injection due to lack of assurance of sterility. The recall affects 8,946 bags distributed nationwide.
Product
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0319-2022·2022-01-05
SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.
Product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0317-2022·2022-01-05
SterRx Fentanyl Citrate Injection recalled for lack of sterility assurance
SterRx is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL) distributed nationwide due to lack of assurance of sterility.
Product
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0305-2022·2022-01-05
Phenylephrine HCL Injection Recalled for Lack of Sterility Assurance
SterRx is recalling approximately 18,948 bags of Phenylephrine HCL in 0.9% Sodium Chloride injection nationwide due to lack of assurance of sterility. The product is distributed across the U.S.A.
Product
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0308-2022·2022-01-05
SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling epinephrine in 0.9% sodium chloride injection (4 mg per 250 mL) nationwide due to lack of assurance of sterility. The recall affects 26,928 bags distributed across the United States.
Product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0302-2022·2022-01-05
dilTIAZem HCl Injection Recalled Due to Sterility Assurance Failure
SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.
Product
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0304-2022·2022-01-05
EPINEPHrine Injection Recall Due to Lack of Sterility Assurance
SterRx is recalling EPINEPHrine 2 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 2,779 bags distributed across the U.S.
Product
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0325-2022·2022-01-05
Sodium Bicarbonate in 5% Dextrose Injection Lacks Sterility Assurance
SterRx is recalling 2,886 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product may pose a risk to patients who receive this intravenous medication.
Product
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0321-2022·2022-01-05
SterRx Norepinephrine 8 mg Sodium Chloride Injection Recalled
SterRx, LLC is recalling 74,508 bags of Norepinephrine 8 mg per 250 mL in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Product
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0311-2022·2022-01-05
SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 684 bags of epinephrine in 0.9% sodium chloride injection nationwide due to lack of assurance of sterility. The product is supplied to hospitals and healthcare facilities.
Product
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0309-2022·2022-01-05
Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling epinephrine in 0.9% sodium chloride injection (5 mg per 250 mL) nationwide due to lack of assurance of sterility. Affected lots are identified by codes S21255/BXA, S21264/BXH, and S21328/BZO.
Product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0318-2022·2022-01-05
SterRx Morphine Sulfate Injection Recalled for Sterility Assurance
SterRx is recalling 880 bags of Morphine Sulfate in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. Patients and healthcare providers should stop using affected units immediately.
Product
MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.
Category
Drug
Distribution
Distributed nationwide