Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

351–375 of 674

SevereFDA (Drugs)·D-0401-2022·2022-02-02
Edge Pharma Edetate Disodium Ophthalmic Solution Recall for Sterility Concerns
Edge Pharma is recalling Edetate Disodium (EDTA) 3% Sterile Ophthalmic Solution due to lack of assurance of sterility. The product is a single-dose eye drop used for topical ophthalmic use.
Product
Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0426-2022·2022-02-02
Vancomycin HCl Injection Recalled for Sterility Assurance Issues
Edge Pharma LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The affected product is a 500 mL pre-filled bag for IV injection.
Product
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0394-2022·2022-02-02
ALUM Concentrate IV Bags Recalled for Lack of Sterility Assurance
Edge Pharma, LLC is recalling ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) IV bags nationwide due to lack of assurance of sterility. The affected product is a prescription intravenous medication supplied in 300 ml bags.
Product
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0396-2022·2022-02-02
Edge Pharma Lidocaine HCl/Epinephrine Injection Lacks Sterility Assurance
Edge Pharma is recalling approximately 8,140 syringes of Lidocaine HCl/Epinephrine sterile buffered injection solution due to lack of assurance of sterility. The product was distributed nationwide.
Product
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0419-2022·2022-02-02
Edge Pharma Phenylephrine/Lidocaine Ophthalmic Solution Sterility Recall
Edge Pharma is recalling Phenylephrine HCl/Lidocaine sterile ophthalmic solution for injection due to lack of assurance of sterility. The recalled product consists of 2,750 single-use syringes distributed nationwide.
Product
Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0395-2022·2022-02-02
Lidocaine HCl Sterile Buffered Solution Recalled for Lack of Sterility Assurance
Edge Pharma is recalling Lidocaine HCl Sterile Buffered Solution for Injection (1%, 10 mL syringes) due to lack of assurance of sterility. The recall affects approximately 4,465 syringes distributed nationwide.
Product
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0416-2022·2022-02-02
Edge Pharma Phenylephrine HCl IV Injection Sterility Assurance Recall
Edge Pharma is recalling Phenylephrine HCl 1mg/10mL single-use syringes for IV injection due to lack of assurance of sterility. The recall affects 6,535 vials distributed nationwide.
Product
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0414-2022·2022-02-02
Eye Drops Recalled for Lack of Sterility Assurance by Edge Pharma
Edge Pharma is recalling a multi-ingredient sterile ophthalmic solution nationwide due to lack of assured sterility. The product is used for topical eye application.
Product
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01
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-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-0408-2022·2022-02-02
Mitomycin-C Sterile Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma is recalling Mitomycin-C Sterile Ophthalmic Solution because the manufacturer cannot assure that the product is sterile. The recall affects 163 syringes distributed nationwide.
Product
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0410-2022·2022-02-02
Moxifloxacin Ophthalmic Injection Syringes Recalled for Sterility Risk
Edge Pharma is recalling Moxifloxacin sterile ophthalmic injection syringes nationwide due to lack of assurance of sterility. The 860 affected syringes were distributed across two lots.
Product
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0377-2022·2022-01-26
SENNA Syrup unit-dose cups recalled for microbial contamination
Lohxa, LLC is recalling SENNA Syrup (sennosides) 8.8 mg/5 mL unit-dose cups due to microbial contamination of the non-sterile product. The recall affects Lot #AM1115S with expiration date 01/2023, distributed nationwide.
Product
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0462-2022·2022-01-26
Semglee Insulin Glargine Prefilled Pens Missing Label
Mylan Pharmaceuticals is recalling approximately 73,175 Semglee (insulin glargine) prefilled pens nationwide because some units have a missing label. Patients should check their pens and contact their pharmacist or doctor if affected.
Product
Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71), packaged in Five 3 mL Prefilled Pens per carton (NDC 49502-0196-75), Rx only, Manufactured in Malaysia for: Mylan Specialty L.P., Morgantown, WV, 26505.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0371-2022·2022-01-19
Teva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance
Teva Pharmaceuticals is recalling Norepinephrine Bitartrate Injection USP due to lack of assurance of sterility. The affected lot is distributed in Tennessee, Mississippi, and Ohio.
Product
Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.
Category
Drug
Distribution
3 states
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-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-0375-2022·2022-01-19
Clobetasol Propionate Ointment Recalled for Microbial Contamination
Taro Pharmaceuticals is recalling Clobetasol Propionate Ointment USP 0.05% due to the presence of R. Pickettii bacteria in a non-sterile product. The affected lot may have been distributed nationwide through retailers.
Product
CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0363-2022·2022-01-05
kleantouch Hand Sanitizer recalled for methanol contamination
Valisa MFG LLC is recalling kleantouch Hand Sanitizer 8 FL OZ pump bottles nationwide because the product contains methanol and was marketed without FDA approval. Consumers should stop using the product immediately.
Product
kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1
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-0320-2022·2022-01-05
SterRx Norepinephrine Injection Recalled Due to Lack of Sterility Assurance
SterRx is recalling 121,584 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The drug is used to treat low blood pressure in critical care settings.
Product
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0316-2022·2022-01-05
SterRx Fentanyl Citrate Injection Recalled for Sterility Assurance Failure
SterRx is recalling fentanyl citrate injection nationwide due to lack of assurance of sterility. The recall affects approximately 10,660 bags of the product.
Product
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0299-2022·2022-01-05
Veklury (Remdesivir) Drug Vials Recalled for Glass Particulate Matter
Gilead Sciences is recalling Veklury (remdesivir) injection vials nationwide due to the presence of glass particulates detected during a customer complaint investigation. The affected lots are 2141001-1A and 2141002-1A with expiration date 01/2024.
Product
VEKLURY — VEKLURY (REMDESIVIR)
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-0314-2022·2022-01-05
SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 1,428 bags of Norepinephrine in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The product is a prescription injectable medication.
Product
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01.
Category
Drug
Distribution
Distributed nationwide

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351–375 of 674