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

4476–4500 of 11819

SevereFDA (Drugs)·D-0046-2020·2019-10-09
KRS Global Biotechnology Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 3,895 syringes of ephedrine sulfate due to a lack of assurance of sterility. The product was distributed nationwide.
Product
ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0073-2020·2019-10-09
KRS Global Biotechnology Recalls Methylcobalamin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,189 vials of Methylcobalamin injection nationwide due to a lack of assurance of sterility.
Product
Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0115-2020·2019-10-09
KRS Global Biotechnology Recalls IV Vitamin B12 Vials for Sterility Concerns
KRS Global Biotechnology is recalling 948 vials of IV Vitamin B12 products due to a lack of assurance of sterility. The recall is nationwide.
Product
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0044-2020·2019-10-09
KRS Global Biotechnology Recalls L-Carnitine Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling L-Carnitine vials nationwide because the company cannot ensure the product is sterile.
Product
L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0074-2020·2019-10-09
KRS Global Biotechnology Recalls IV Magnesium and Calcium Vials for Sterility Concerns
KRS Global Biotechnology is recalling 878 vials of IV magnesium and calcium solution due to a lack of assurance of sterility.
Product
Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0102-2020·2019-10-09
KRS Global Biotechnology Recalls Sodium Citrate and Gentamicin Vials
KRS Global Biotechnology is recalling 150 vials of Sodium Citrate and Gentamicin solution due to a lack of assurance of sterility.
Product
Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0006-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Atropine Sulfate Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.02% because the product's sterility cannot be guaranteed.
Product
C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0051-2020·2019-10-09
FDA Recalls Fentanyl IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,882 bags of fentanyl citrate IV solution nationwide due to a lack of assurance of sterility.
Product
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0107-2020·2019-10-09
KRS Global Biotechnology Recalls Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling Cyclopentolate HCl, Phenylephrine HCl, and Tropicamide ophthalmic solution because the company cannot guarantee the product is sterile.
Product
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 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, FL 33487. NDC 3321678092
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0049-2020·2019-10-09
FDA Recalls Fentanyl IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.
Product
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
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-0121-2020·2019-10-09
Torrent Pharma Recalls Losartan Potassium Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium Tablets 50mg because FDA testing found an impurity above acceptable levels.
Product
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
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-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-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-0103-2020·2019-10-09
KRS Global Biotechnology Recalls Succinylcholine Chloride Syringes for Sterility Concerns
KRS Global Biotechnology is recalling 7,905 syringes of Succinylcholine Chloride (PF) due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.
Product
SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0081-2020·2019-10-09
KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,464 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
NORepinephrine in 0.9% Sodium Chloride (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 3321678406
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-0088-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 708 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), 25 mg / 250 mL (0.1 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 3321677861
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0099-2020·2019-10-09
Sermorelin Acetate Vials Recalled for Lack of Sterility Assurance
KRS Global Biotechnology is recalling Sermorelin Acetate vials due to a lack of assurance of sterility. The recall covers 341 vials distributed nationwide.
Product
Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588
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-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-0005-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Atropine Sulfate Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.01% due to a lack of assurance of sterility.
Product
C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0055-2020·2019-10-09
KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,625 syringes of Glycopyrrolate (PF) 1 mg/5 mL due to a lack of assurance of sterility.
Product
GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 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. NDC03321678317
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

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4476–4500 of 11819