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

4576–4600 of 8589

SevereFDA (Drugs)·D-1361-2016·2016-07-27
PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 80 bags of compounded morphine and bupivacaine injectable solution due to the presence of glass particulate matter.
Product
0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1371-2016·2016-07-27
PharMEDium Recalls Sufentanil and Bupivacaine Cassettes Due to Glass Particulates
PharMEDium Services is recalling 325 cassettes of compounded sufentanil and bupivacaine because the active ingredient was contaminated with glass particulate matter.
Product
0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1428-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter
PharMEDium Services, LLC is recalling 115 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1367-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination
PharMEDium Services, LLC is recalling 355 bags of 0.2% Bupivacaine HCl sterile injectable drugs because the active ingredient was contaminated with glass particulate matter.
Product
0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1407-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 380 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1414-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 345 bags of compounded fentanyl and bupivacaine injectable solutions nationwide due to the presence of glass particulate matter.
Product
3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxte
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1409-2016·2016-07-27
Pharmedium Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates
Pharmedium Services is recalling 435 syringes of compounded hydrocodone and bupivacaine due to glass particulate contamination.
Product
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1401-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates
PharMEDium Services is recalling 90 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 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1316-2016·2016-07-20
Pharmakon Recalls Morphine Sulfate Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 300 bags of Morphine Sulfate 1mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Product
Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1177-2016·2016-07-20
Medaus Recalls Cesium Chloride Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Cesium Chloride 600mg/mL vials because the company cannot assure the sterility of the product.
Product
CESIUM CHLORIDE 600MG/ML (PF), 10ML 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-1286-2016·2016-07-20
Pharmakon Recalls Fentanyl Citrate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 20 syringes of Fentanyl Citrate 25 mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.
Product
Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67
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-1341-2016·2016-07-20
Pharmakon Recalls Midazolam HCl Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 10 bags of Midazolam HCl 1mg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0989-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1325-2016·2016-07-20
Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 90 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1265-2016·2016-07-20
Pharmakon Recalls Epinephrine Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 280 vials of compounded Epinephrine injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Product
Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1302-2016·2016-07-20
Pharmakon Recalls Magnesium Sulfate Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 10 bags of Magnesium Sulfate 1GM in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1175-2016·2016-07-20
Medaus Recalls B-Complex and Lidocaine Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of B-Complex with Methyl B12 and Lidocaine vials because the company cannot guarantee the product is sterile.
Product
B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
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-1184-2016·2016-07-20
Medaus Recalls Folic Acid Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Folic Acid 10mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.
Product
FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1297-2016·2016-07-20
Pharmakon Recalls Oxytocin Infusion Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 72 units of compounded Oxytocin 10 Units in Lactated Ringers due to a lack of assurance of sterility.
Product
Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1281-2016·2016-07-20
Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 25 units of Morphine Sulfate syringes because the company cannot guarantee the products are sterile.
Product
Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78
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
SevereFDA (Drugs)·D-1210-2016·2016-07-20
Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns
Medaus, Inc. is recalling Lipo-Injection vials because the company cannot ensure the product is sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.
Product
LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1273-2016·2016-07-20
Pharmakon Recalls Promethazine Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 40 units of compounded Promethazine injection due to a lack of assurance of sterility. The product was distributed nationwide to VA and DOD facilities.
Product
Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41
Category
Drug
Distribution
Distributed nationwide

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4576–4600 of 8589