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

7326–7350 of 18015

SevereFDA (Drugs)·D-0071-2020·2019-10-09
KRS Global Biotechnology Recalls Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling Lidocaine/Bupivacaine/Hyaluronidase ophthalmic injections due to a lack of assurance of sterility.
Product
LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678362
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0076-2020·2019-10-09
KRS Global Biotechnology Recalls Moxifloxacin Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling Moxifloxacin 0.1% ophthalmic injection syringes due to a lack of assurance of sterility. The recall covers 9,920 syringes distributed nationwide.
Product
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0007-2020·2019-10-09
Colonia Care Pharmacy Recalls Calcium Gluconate Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of Calcium Gluconate 1% Injection because the sterility of the product cannot be guaranteed.
Product
C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0011-2020·2019-10-09
Colonia Care Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Gentamicin injection because the sterility of the product cannot be guaranteed.
Product
C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0072-2020·2019-10-09
KRS Global Biotechnology Recalls Lyophilized Injection Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 497 vials of a lyophilized injection product because the company cannot ensure the product is sterile.
Product
Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0087-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 228 bags of Phenylephrine HCl IV infusion due to a lack of assurance of sterility.
Product
PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0052-2020·2019-10-09
KRS Global Fluorescein Vials Recalled for Sterility Assurance Issues
KRS Global Biotechnology is recalling Fluorescein vials because the company cannot guarantee the product is sterile.
Product
Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0070-2020·2019-10-09
KRS Global Biotechnology Recalls Lidocaine and Hyaluronidase Syringes for Sterility Concerns
KRS Global Biotechnology is recalling Lidocaine HCl and Hyaluronidase syringes due to a lack of assurance of sterility. The recall covers 2,615 syringes distributed nationwide.
Product
Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678368
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0078-2020·2019-10-09
KRS Global Biotechnology Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns
KRS Global Biotechnology is recalling Neostigmine Methylsulfate syringes due to a lack of assurance of sterility. The recall covers 3,410 syringes distributed nationwide.
Product
NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0095-2020·2019-10-09
FDA Recalls Sermorelin Vials Due to Lack of Sterility Assurance
KRS Global Biotechnology is recalling 647 vials of Sermorelin and related peptides because the company cannot ensure the products are sterile.
Product
Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0080-2020·2019-10-09
KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 528 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility. The product was distributed nationwide.
Product
NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0116-2020·2019-10-09
KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling 242 droptainers of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.
Product
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, F
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0085-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection
KRS Global Biotechnology is recalling 3,150 vials of Phenylephrine HCl and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.
Product
PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0017-2020·2019-10-09
Colonia Care Pharmacy Recalls C-MB12 NAC Injection Syringes for Sterility Concerns
Colonia Care Pharmacy is recalling 15 syringes of C-MB12 NAC injection solution because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
Product
C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0058-2020·2019-10-09
KRS Global Biotechnology Recalls Human Chorionic Gonadotropin Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,219 vials of Human Chorionic Gonadotropin 5,000 Units due to a lack of assurance of sterility. The recall is nationwide.
Product
Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1883-2019·2019-10-09
Akorn Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns
Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, due to out-of-specification container closure test results that cannot guarantee sterility.
Product
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0039-2020·2019-10-09
KRS Global Biotechnology Recalls Alpha Lipoic Acid Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 77 vials of Alpha Lipoic Acid for IV use nationwide due to a lack of assurance of sterility.
Product
Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0112-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 5 B Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 616 vials of Vitamin 5 B for IM use because the company cannot ensure the product is sterile.
Product
Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0091-2020·2019-10-09
KRS Global Biotechnology Recalls Quadmix #13A Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 91 vials of Quadmix #13A because the company cannot ensure the product is sterile.
Product
Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0105-2020·2019-10-09
FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 3,820 syringes of Succinylcholine Chloride because the company cannot guarantee the product is sterile.
Product
SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0111-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin D Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 508 vials of Vitamin 10 D Lyophilized due to a lack of assurance of sterility. The product is distributed nationwide.
Product
Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0104-2020·2019-10-09
FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,350 syringes of Succinylcholine Chloride (PF) because the company cannot ensure the product is sterile.
Product
SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0113-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 470 vials of Vitamin 9 Lyophilized for IM use nationwide because the product lacks assurance of sterility.
Product
Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0082-2020·2019-10-09
KRS Global Biotechnology Recalls Norepinephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,760 bags of Norepinephrine in 5% Dextrose IV solution due to a lack of assurance of sterility.
Product
Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0084-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection
KRS Global Biotechnology is recalling 825 syringes of Phenylephrine and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.
Product
Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441
Category
Drug
Distribution
Distributed nationwide

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7326–7350 of 18015