Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

4651–4675 of 4878

SevereFDA (Drugs)·D-0742-2021·2021-08-25
Teva Alprostadil Injection Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling one lot of Alprostadil Injection USP due to lack of assurance of sterility. The affected product was distributed nationwide, including Puerto Rico.
Product
Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0735-2021·2021-08-25
Teva Vecuronium Bromide Injection Recalled for Sterility Assurance
Teva Pharmaceuticals USA is recalling Vecuronium Bromide for Injection 10 mg vials nationwide due to lack of assurance of sterility. The recall affects 62,358 vials distributed across multiple lots.
Product
Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0874-2021·2021-08-25
BBQ Seasoning Recalled Due to Salmonella Contamination
Mane Inc is recalling BBQ seasoning products because an ingredient tested positive for Salmonella. The recall affects seasoning distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.
Product
BBQ Seasoning Packaged in 50lb poly bag/cardboard box combo and kraft paper bags
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0743-2021·2021-08-25
Methylprednisolone Acetate Injectable Suspension recalled for sterility concerns
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials distributed nationwide, including Puerto Rico.
Product
Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0924-2021·2021-08-25
HiPP UK Stage 1 Infant Milk Formula Lacks Required FDA Approval
Able Groupe Inc is recalling HiPP UK Stage 1 Combiotic First Infant Milk Formula because required pre-market FDA notifications were not submitted. Some products contain insufficient iron and lack mandatory labeling.
Product
HiPP UK Stage 1 Combiotic First Infant Milk Formula
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0737-2021·2021-08-25
Leucovorin Calcium Injection Recalled Due to Sterility Concerns
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Product
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0925-2021·2021-08-25
HiPP UK Stage 2 Infant Formula Recalled for Missing FDA Notifications and Improper Labeling
Able Groupe Inc is recalling HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English-language labeling as required by federal regulations.
Product
HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0875-2021·2021-08-25
Sweet & Smoky BBQ Seasoning Recalled for Salmonella
Mane Inc is recalling Sweet & Smoky BBQ seasoning packaged in 50lb kraft paper bags because an ingredient tested positive for Salmonella. The affected product was distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.
Product
SWEET & SMOKY BBQ Packaged in 50lb kraft paper bags
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0916-2021·2021-08-25
Holle Bio Stage 1 Organic Infant Formula Recall for Inadequate Iron Content and Labeling
Able Groupe Inc is recalling Holle Bio Stage 1 Organic Infant Milk Formula because the product may contain insufficient iron for some infants and lacks required FDA labeling statements. The recall affects approximately 76,000 units sold directly through littlebundle.com.
Product
Holle Bio Stage 1 Organic Infant Milk Formula
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0873-2021·2021-08-25
Bacon Ranch Seasoning Recalled for Salmonella Contamination
Mane Inc is recalling Flavored Bacon Ranch Seasoning packaged in 25lb kraft paper bags due to Salmonella detected in an ingredient used during manufacturing. The affected product was distributed to manufacturers in Ohio, Indiana, Minnesota, and Oregon.
Product
Flavored Bacon Ranch Seasoning Packaged in 25lb kraft paper bags
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-2244-2021·2021-08-25
Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect
Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.
Product
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0747-2021·2021-08-25
Leucovorin Calcium for Injection recalled for lack of sterility assurance
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.
Product
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
Category
Drug
Distribution
Distributed nationwide
SevereCPSC·21186·2021-08-18
Ravin White Arrow Nocks Recalled for Injury Risk
Ravin Crossbows is recalling white arrow nocks that can fail to engage properly with the bowstring, allowing the crossbow to discharge unexpectedly during re-nocking and causing finger injuries. About 220,000 units are affected.
Product
Ravin® white arrow nocks
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0716-2021·2021-08-18
Injectable Drug Recalled for Non-Sterility Risk
Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Food)·F-0899-2021·2021-08-18
McCormick Culinary Italian Seasoning Recalled for Salmonella Risk
McCormick & Company is recalling McCormick Culinary Italian Seasoning (1.75 lbs. plastic jugs) distributed across multiple U.S. states and Canada due to potential Salmonella contamination.
Product
McCormick Culinary Italian Seasoning 1.75 lbs. , Plastic Jugs (Large Plastic Bottles), (3) 3 packages per case.
Category
Food
Distribution
15 states
SevereFDA (Devices)·Z-2189-2021·2021-08-18
Heart Pump Device Recalled for Increased Mortality and Device Failure
Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.
Product
HeartWare HVAD Pump Implant Kit, REF 1104
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0706-2021·2021-08-18
Fentanyl-Bupivacaine Injectable Recalled for Non-Sterility Risk
Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.
Product
FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0718-2021·2021-08-18
Compounded Progesterone Oil Recalled for Non-Sterility Risk
People's Custom Rx is recalling C-Progesterone Oil 100 mg/mL compounded vials due to non-sterility concerns. The recall affects 14 vials distributed in Mississippi and Tennessee.
Product
C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117
Category
Drug
Distribution
2 states
SevereFDA (Food)·F-0900-2021·2021-08-18
Frank's Red Hot Buffalo Ranch Seasoning Recalled for Salmonella Contamination
McCormick & Company is recalling Frank's Red Hot Buffalo Ranch Seasoning due to potential Salmonella contamination. The product was distributed to multiple U.S. states and Canada.
Product
Frank s Red Hot Buffalo Ranch Seasoning 153g, Plastic Bottles, 36 packages per case
Category
Food
Distribution
15 states
SevereFDA (Drugs)·D-0715-2021·2021-08-18
Injectable drug recalled due to non-sterility concern
Med Shop Total Care is recalling morphine-bupivacaine-fentanyl injectable syringes due to non-sterility. The affected lot was distributed in Texas and Puerto Rico.
Product
MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0708-2021·2021-08-18
Injectable Drug Syringes Recalled for Non-Sterility
Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.
Product
HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop
Category
Drug
Distribution
0 states
SevereFDA (Food)·F-0871-2021·2021-08-18
Dark Chocolate Malt Balls recalled for undeclared peanuts
DSD Merchandisers is recalling Dark Chocolate Malt Balls because some containers were filled with Dark Chocolate Peanut Butter malt balls instead, creating a risk for consumers with peanut allergies who may not be aware of the peanut content.
Product
Dark Chocolate Malt Balls in plastic container; 9 oz./ 255g UPC: 6 5143370179 0 Packed on the same equipment as products that contain milk, eggs, tree nuts, peanuts, wheat and soy. Distributed by DSD Merchandisers, Inc., Livermore, CA 64551
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0713-2021·2021-08-18
Morphine-Bupivacaine-Ketamine Injectables Recalled for Non-Sterility
Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.
Product
MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Category
Drug
Distribution
0 states
SevereFDA (Devices)·Z-2110-2021·2021-08-18
Spectrum IQ Infusion System Recalled for Connectivity Errors
Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.
Product
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2165-2021·2021-08-18
Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch
Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.
Product
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Category
Medical Device
Distribution
Distributed nationwide