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

7376–7400 of 11823

SevereFDA (Drugs)·D-1397-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulate
Pharmedium Services, LLC is recalling 250 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution because the active pharmaceutical ingredient was contaminated with glass particulate.
Product
2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1365-2016·2016-07-27
Pharmedium Recalls Bupivacaine HCl Bags Due to Glass Particulate Matter
Pharmedium Services, LLC is recalling 8,581 bags of 0.125% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 6
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1418-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 455 bags of compounded fentanyl and bupivacaine injectable solutions distributed nationwide. The recall is due to the presence of glass particulate matter in the active pharmaceutical ingredient.
Product
4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1392-2016·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulate
PharMEDium Services is recalling 950 bags of compounded fentanyl and bupivacaine infusions because glass particulate was found in the active pharmaceutical ingredient.
Product
2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1398-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
Pharmedium Services, LLC is recalling 940 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1432-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services, LLC is recalling 180 syringes of compounded Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 15 mL in 20 mL BD Syringe, Service Code 2T6993Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-993-86
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1390-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 60 bags of compounded fentanyl and bupivacaine injectable solution nationwide because glass particulates were found in the active pharmaceutical ingredient.
Product
2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50 ,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1394-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates
PharMEDium Services is recalling 1,280 cassettes of compounded fentanyl and bupivacaine infusions because the active ingredient was contaminated with glass particulate matter.
Product
2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx On
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1366-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Cassettes Due to Glass Particulate
PharMEDium Services, LLC is recalling 315 cassettes of 0.15% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.
Product
0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1391-2016·2016-07-27
FDA Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 17,990 bags of compounded fentanyl and bupivacaine injectable solutions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate.
Product
2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1363-2016·2016-07-27
PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 15 bags of compounded morphine and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83
Category
Drug
Distribution
Distributed nationwide
HighCPSC·16232·2016-07-27
Novel Laboratories Recalls Zolpidem Tartrate Tablets for Packaging Defect
Novel Laboratories is recalling Zolpidem Tartrate sublingual tablets because the packaging fails to meet child-resistant closure requirements, posing a risk of poisoning to children.
Product
Zolpidem Tartrate Sublingual tablets
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1364-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate
PharMEDium Services is recalling 4,081 bags of 0.1% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1212-2016·2016-07-20
Medaus Recalls Manganese Chloride Vials Due to Sterility Concerns
Medaus, Inc. is recalling Manganese Chloride 0.1mg/mL vials because the company cannot guarantee the product is sterile.
Product
MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1310-2016·2016-07-20
Pharmakon Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 100 units of compounded Fentanyl and Bupivacaine syringes due to a lack of assurance of sterility.
Product
Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1167-2016·2016-07-20
Medaus Recalls B-Complex #3 Vials Due to Sterility Concerns
Medaus, Inc. is recalling B-Complex #3 vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1311-2016·2016-07-20
Pharmakon Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Norepinephrine Bitartrate 4 mg in 5% Dextrose bags because the company cannot ensure the products are sterile.
Product
Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1198-2016·2016-07-20
Medaus Recalls L-Glutathione Vials Due to Sterility Concerns
Medaus, Inc. is recalling L-Glutathione 100mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1284-2016·2016-07-20
Pharmakon Recalls Hydromorphone Cadd Cassettes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 10 units of Hydromorphone HCI cadd cassettes because the company cannot guarantee the products are sterile.
Product
Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1283-2016·2016-07-20
Pharmakon Recalls Morphine Sulfate Cadd Cassettes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 units of Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassettes due to a lack of assurance of sterility.
Product
Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1290-2016·2016-07-20
Pharmakon Recalls Provocholine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 142 units of Provocholine pre-diluted syringes nationwide due to a lack of assurance of sterility.
Product
Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1191-2016·2016-07-20
Medaus Recalls Hydroxy B12 Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Hydroxy B12 5mg/mL vials because the company cannot ensure the product is sterile.
Product
HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1312-2016·2016-07-20
Pharmakon Recalls Hydromorphone IV Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 675 units of compounded Hydromorphone HCI IV bags due to a lack of assurance of sterility.
Product
Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1305-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 560 vials of Hydromorphone HCl 0.4mg/mL in 30 mL syringes due to a lack of assurance of sterility.
Product
HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1208-2016·2016-07-20
Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the FDA determined there is a lack of assurance of sterility.
Product
LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS
Category
Drug
Distribution
Distributed nationwide

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7376–7400 of 11823