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.

17951–17975 of 29217

SevereFDA (Drugs)·D-1373-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates
PharMEDium Services is recalling specific lots of compounded fentanyl and bupivacaine infusions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.
Product
1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1424-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services, LLC is recalling 562 bags of sterile injectable fentanyl and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1443-2016·2016-07-27
GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Cross Contamination
GlaxoSmithKline is recalling Bactroban Cream (Mupirocin Calcium Cream 2%) due to penicillin cross-contamination. The recall covers 7,480 tubes distributed nationwide and in Puerto Rico.
Product
Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1417-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services, LLC is recalling 1,015 bags of compounded fentanyl and bupivacaine injectable solutions because the active ingredient was contaminated with glass particulate matter.
Product
3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1695-2016·2016-07-27
Clif Bar Mojo Mountain Mix trail bars recalled for Listeria risk
Clif Bar and Company is recalling Mojo Mountain Mix trail bars because a supplier notified them that sunflower kernels may be contaminated with Listeria monocytogenes.
Product
CLIF BAR Mojo Mountain Mix trail bar, 45 g bar UPC: 7-22252-10561-5; 12 count packages; INGREDIENTS: Organic Brown Rice Syrup, Soy Rice Crisps (Soy Protein Isolate, Organic Rice Flour, Calcium Carbonate), Organic Peanuts, Organic Raisins, Almonds, Organic Chocolate Chips…
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-1387-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter
PharMEDium Services, LLC is recalling 1,277 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2213-2016·2016-07-27
AMD-RITMED Conforming Stretch Gauze Bandages Recalled for Sterility Failure
AMD-RITMED is recalling specific lots of sterile conforming stretch gauze bandages because FDA testing showed they did not meet sterility requirements.
Product
AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC.…
Category
Medical Device
Distribution
3 states
SevereFDA (Drugs)·D-1396-2016·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates
Pharmedium Services is recalling 97,716 bags of sterile injectable fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1433-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate
PharMEDium Services, LLC is recalling 79 syringes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the active pharmaceutical ingredient.
Product
6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1426-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services, LLC is recalling 3,927 syringes of compounded fentanyl and bupivacaine because glass particulates were found in the active pharmaceutical ingredient.
Product
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1406-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services, LLC is recalling 220 cassettes of compounded fentanyl and bupivacaine injectable drugs because the active ingredient was contaminated with glass particulate.
Product
2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Category
Drug
Distribution
Distributed nationwide
SevereUSDA FSIS·066-2016·2016-07-27
Tim Hortons Chicken Noodle Soup Mix Recalled for Import Inspection Failure
The TDL Group Corp. is recalling approximately 636 pounds of Tim Hortons Chicken Noodle Soup Mix because the products were imported from Canada without receiving required FSIS re-inspection.
Product
The TDL Group Corp. Recalls Dried Chicken Soup Mix Products Distributed Without Benefit of Import Inspection
Category
Food
Distribution
4 states
SevereFDA (Drugs)·D-1388-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
PharMEDium Services, LLC is recalling 230 syringes of compounded Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1422-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 655 bags of compounded fentanyl and bupivacaine injectable solutions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.
Product
5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1378-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 65 bags of compounded fentanyl and bupivacaine injectable solution because glass particulate was found in the active pharmaceutical ingredient.
Product
10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1416-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services is recalling 5,727 sterile injectable cassettes containing fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate.
Product
3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1369-2016·2016-07-27
PharMEDium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 140 bags of compounded sufentanil and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1742-2016·2016-07-27
Rucker's Sweet N Salty Sunflower Kernels Recalled for Listeria Contamination
Rucker's Wholesale & Service Co. is recalling 504 bags of Sweet N Salty sunflower kernels due to Listeria monocytogenes contamination.
Product
SWEET N SALTY 7.5 OZ.packaged in a clear plastic bag with white sticky label. The product is under UPC code 052545003398 and includes the brand names Big R Store's, Coastal, and Fin feather Fur Outfitter's.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1382-2016·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate
PharMEDium Services is recalling 740 syringes of compounded fentanyl and bupivacaine because glass particulate was found in the active ingredient.
Product
10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1431-2016·2016-07-27
FDA Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates
PharMEDium Services is recalling 5 syringes of compounded hydrocodone and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1420-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate
Pharmedium Services, LLC is recalling 936 cassettes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the sterile injectable solution.
Product
4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·16V560000·2016-07-27
Jayco Recalls Travel Trailers Due to Brake Control Defect
Jayco is recalling 2016-2017 travel trailers equipped with Sway Command systems because the trailer brakes may fail to function after a sway event.
Product
JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER, JAYCO FIFTH WHEEL JAY FEATHER, OCTANE, EAGLE, JAY FLIGHT
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1383-2016·2016-07-27
Pharmedium Recalls Hydrocodone and Bupivacaine Bags Due to Glass Particulate
Pharmedium Services is recalling 55 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1425-206·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate Matter
PharMEDium Services is recalling 2,713 syringes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1403-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine HCl sterile injectable drugs due to the presence of glass particulate matter.
Product
2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50
Category
Drug
Distribution
Distributed nationwide