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

4401–4425 of 11852

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
SevereFDA (Drugs)·D-0124-2020·2019-10-09
Torrent Pharma Recalls Losartan Potassium/Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide Tablets because FDA testing found an impurity above acceptable levels.
Product
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0092-2020·2019-10-09
KRS Global Biotechnology Recalls Quadmix # 19 Due to Sterility Concerns
KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.
Product
Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0028-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed.
Product
C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
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-0114-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 9A/B Lyophilized Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,325 vials of Vitamin 9A/B Lyophilized for IM use due to a lack of assurance of sterility.
Product
Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0042-2020·2019-10-09
KRS Global Biotechnology Recalls Bacteriostatic Water for Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling Bacteriostatic Water for Injection vials because the product lacks assurance of sterility.
Product
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0032-2020·2019-10-09
Colonia Care Pharmacy Recalls Tacrolimus Ophthalmic Suspension Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific lots of C-Tacrolimus 0.03% ophthalmic suspension because the sterility of the product cannot be guaranteed.
Product
C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0083-2020·2019-10-09
KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling Oxytocin IV bags because the company cannot guarantee the product is sterile.
Product
OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0109-2020·2019-10-09
KRS Global Biotechnology Recalls Ophthalmic Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 465 syringes of a sterile ophthalmic solution because the company cannot guarantee the product's sterility.
Product
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0098-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns
KRS Global Biotechnology is recalling Sermorelin Acetate 3 mg vials because the company cannot ensure the product is sterile.
Product
Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0054-2020·2019-10-09
KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling Glycopyrrolate single-dose syringes nationwide because the company cannot guarantee the product is sterile.
Product
GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0020-2020·2019-10-09
Colonia Care Pharmacy Recalls Sterility-Compromised C-Papav/Phentol/PGE1 Vials
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because sterility cannot be guaranteed. The product was distributed via patient-specific prescriptions in New Jersey.
Product
C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
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-0101-2020·2019-10-09
Sodium Bicarbonate Syringes Recalled for Lack of Sterility Assurance
KRS Global Biotechnology is recalling 540 syringes of Sodium Bicarbonate 8.4% for IV use due to a lack of assurance of sterility.
Product
Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0004-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Albumin 5% Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Albumin 5% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed via patient-specific prescriptions in New Jersey.
Product
C-ALBUMIN 5% OPHTH SOLUTION, 10 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-0075-2020·2019-10-09
KRS Global Biotechnology Recalls Moxifloxacin Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,290 syringes of Moxifloxacin 0.1% ophthalmic injection nationwide due to a lack of assurance of sterility.
Product
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0033-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Urea 40% Bladder Instill Due to Sterility Concerns
Colonia Care Pharmacy is recalling 7 vials of C-Urea 40% Bladder Instill because the product's sterility cannot be guaranteed.
Product
C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0106-2020·2019-10-09
KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure the product's sterility.
Product
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Bl
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0018-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Methylcobalamin Injections Due to Sterility Concerns
Colonia Care Pharmacy is recalling 191 syringes of C-Methylcobalamin 25mg/mL injection because the product's sterility cannot be guaranteed.
Product
C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
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-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-0060-2020·2019-10-09
FDA Recalls Hyaluronidase Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling 928 vials of Hyaluronidase Ophthalmic Injection because the product lacks assurance of sterility.
Product
Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 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 3321678359
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-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

How to read this listing

Filters

4401–4425 of 11852