Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

11451–11475 of 29163

SevereFDA (Drugs)·D-1762-2019·2019-08-21
Infusion Options Recalls Cytarabine Products Due to Sterility Concerns
Infusion Options, Inc. is recalling Cytarabine products in New York due to a lack of assurance of sterility.
Product
Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytarabine 70 MG QS 6 ML PF NS SYRINGE; Cytarabine 100 MG QS 3 ML PF NS SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1774-2019·2019-08-21
ERBITUX Infusions Recalled for Lack of Sterility Assurance
Infusion Options, Inc. is recalling ERBITUX infusion bags in New York due to a lack of assurance of sterility.
Product
ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ 425 ml IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2264-2019·2019-08-21
Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery to remove the broken end.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1781-2019·2019-08-21
Infusion Options Recalls Gemcitabine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Gemcitabine infusion bags in New York due to a lack of assurance of sterility.
Product
Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine…
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2066-2019·2019-08-21
Medline Primary Warmer Pack Recalled for Unsafe Aluminum Levels
Medline Industries is recalling 4,680 Primary Warmer Packs because the included Vyaire enFlow cartridge may release unsafe aluminum levels into the infusate.
Product
Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow…
Category
Medical Device
Distribution
1 state
SevereFDA (Drugs)·D-1820-2019·2019-08-21
American Health Packaging Recalls Aspirin and Dipyridamole Capsules
American Health Packaging is recalling specific lots of Aspirin and Extended-release Dipyridamole Capsules due to an unknown impurity found in stability samples.
Product
Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules per carton (5 blister cards x 4 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-305-32; NDC Blister Pack: 60687-305-33
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1776-2019·2019-08-21
Infusion Options Recalls Etoposide Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Etoposide infusion bags in New York due to a lack of assurance of sterility.
Product
Etoposide 184 MG / 500 ml NS IVPB; Etoposide 176 MG/ 500 ml 0.9% NACL IVPB; Etoposide 170 MG / 500 ml 0.9% NACL IVPB; Etoposide 152 MG / 500 ml 0.9% NACL IVPB; Etoposide 275 MG / 500 ml NS IVPB; Etoposide 270 MG / 500 ml NS IVPB; Etoposide 90 MG / 500 ml NS IVPB; Etoposide 160…
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-2261-2019·2019-08-21
Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1800-2019·2019-08-21
Infusion Options Recalls Paclitaxel Protein Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling specific paclitaxel protein infusion products in New York due to a lack of assurance of sterility.
Product
PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 355 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1795-2019·2019-08-21
Infusion Options Recalls OPDIVO Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling OPDIVO 200 mg and 480 mg infusion products in New York due to a lack of assurance of sterility.
Product
OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Food)·F-1994-2019·2019-08-21
Mountain Rose Herbs Recalls Fennel Seed for Salmonella Risk
Mountain Rose Herbs is recalling Fennel Whole Seed due to potential Salmonella contamination. The product was sold in the US and Canada.
Product
Fennel Whole Seed was packaged in a clear plastic bag or poly-woven bags sold in bulk form, net weight ranges from 4 ounces to 50 pounds, sold under Mountain Rose Herbs brand. The label is read in parts: "***Fennel Seed Whole ***NET WT *** Origin: Egypt *** MOUNTAIN ROSE…
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·19V616000·2019-08-21
Mack Recalls 2015 Pinnacle Trucks Due to Front Axle Fracture Risk
Mack Trucks is recalling 2015 Pinnacle (CXU) vehicles because front steer axles may have missed a heat-treating step, potentially causing them to fracture and leading to a loss of vehicle control.
Product
MACK — MACK PINNACLE (CXU)
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1748-2019·2019-08-21
Infusion Options Recalls ALIMTA Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling ALIMTA 785 mg and 1000 mg intravenous infusion bags in New York due to a lack of assurance of sterility.
Product
ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1804-2019·2019-08-21
Infusion Options Recalls Perjeta IV Bags Due to Sterility Concerns
Infusion Options, Inc. is recalling Perjeta 420 mg/250 mL IV bags in New York due to a lack of assurance of sterility.
Product
PERJETA 420 MG/250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1756-2019·2019-08-21
Infusion Options Recalls Carboplatin Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Carboplatin infusion bags because the company cannot guarantee the products are sterile.
Product
CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARBOPLATIN 750 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 895 MG / 250 ML NACL 0.9% IVPB; CARBOPLATIN 235 MG / 250ml NS IVPB CARBOPLATIN 716 MG / 250 ML D5W IVPB; CARBOPLATIN 400 MG / 500 ML NS IVPB…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1813-2019·2019-08-21
Infusion Options Recalls SOLIRIS IV Products Due to Sterility Concerns
Infusion Options, Inc. is recalling SOLIRIS 1200 mg and 900 mg IV products in New York due to a lack of assurance of sterility.
Product
SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1752-2019·2019-08-21
Infusion Options Recalls Bevacizumab Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Bevacizumab infusion bags in New York due to a lack of assurance of sterility.
Product
BEVACIZUMAB 784 MG / 100 ML NS IVPB; BEVACIZUMAB 350 MG/100 ml NS IVPB; BEVACIZUMAB 425 MG/ 100 ml NS IVPB; BEVACIZUMAB 420 MG/100 ml 0.9% NACL IVPB; BEVACIZUMAB 556 mg/100 ml NS IVPB BEVACIZUMAB 330 MG / 100 ML NS IVPB; BEVACIZUMAB 790 MG / 100 ML NS IVPB; BEVACIZUMAB 470 MG…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1805-2019·2019-08-21
Infusion Options Recalls Pertuzumab IV Bags Due to Sterility Concerns
Infusion Options, Inc. is recalling Pertuzumab IV bags in New York due to a lack of assurance of sterility.
Product
PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1780-2019·2019-08-21
GAZYVA Infusion Recall Due to Lack of Sterility Assurance
Infusion Options, Inc. is recalling GAZYVA 100 mg and 900 mg infusion products in New York due to a lack of assurance of sterility.
Product
GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1787-2019·2019-08-21
Infusion Options Recalls Irinotecan Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Irinotecan infusion products in New York due to a lack of assurance of sterility.
Product
IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250 MG/250 ML NS IVPB; IRINOTECAN 315 MG / 250 ML NS IVPB; IRINOTECAN 155 MG / 500 ml D5W IVPB; IRINOTECAN 75 MG / 250 ML NS IVPB; IRINOTECAN 140 MG / 250 ML NS IVPB; IRINOTECAN 317 MG /500 ML…
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1766-2019·2019-08-21
Infusion Options Recalls Decitabine Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Decitabine 40 mg/100 ml infusions in New York due to a lack of assurance of sterility.
Product
DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1778-2019·2019-08-21
Infusion Options Recalls FOSAPREPITANT Due to Sterility Assurance Concerns
Infusion Options, Inc. is recalling FOSAPREPITANT 150 mg/150 ml NS IVPB in New York due to a lack of assurance of sterility.
Product
FOSAPREPITANT 150 mg/150 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1793-2019·2019-08-21
Infusion Options Recalls Nivolumab IV Bags Due to Sterility Concerns
Infusion Options, Inc. is recalling Nivolumab IV bags in New York due to a lack of assurance of sterility.
Product
NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUMAB 165 mg / 100 ML NS IVPB; NIVOLUMAB 240 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1758-2019·2019-08-21
Infusion Options Recalls Cetuximab IV Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling Cetuximab 335 mg/167.5 mL IV infusions in New York due to a lack of assurance of sterility.
Product
CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1808-2019·2019-08-21
Infusion Options Recalls Remicade Infusions Due to Sterility Concerns
Infusion Options, Inc. is recalling various Remicade infusion bags in New York due to a lack of assurance of sterility.
Product
REMICADE 680 MG QS 250 ML 0.9% NACL IVPB; REMICADE 270 MG QS 250 ML 0.9% NACL IV; REMICADE 730 MG QS 250 ML 0.9% NACL IVPB REMICADE 330 MG QS 250 ML 0.9% NACL IVPB; REMICADE 740 MG IN 250 ML NS IVPB; REMICADE 650 MG / 250 ml 0.9% NACL; REMICADE 1200 MG/250 ml 0.9% NACL IVPB…
Category
Drug
Distribution
1 state