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

7401–7425 of 11856

SevereFDA (Drugs)·D-1423-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services is recalling 3,474 bags of sterile injectable fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate.
Product
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K
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-1372-2016·2016-07-27
PharMEDium Recalls Bupivacaine HCl Injectable Bags Due to Glass Particulate
PharMEDium Services, LLC is recalling 866 bags of 0.5% Bupivacaine HCl injectable solution because the active ingredient was contaminated with glass particulate.
Product
0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1400-2016·2016-07-27
PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate
PharMEDium Services, LLC is recalling 480 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 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1385-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter
PharMEDium Services is recalling 30 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1380-2016·2016-07-27
Pharmedium Recalls Fentanyl and Bupivacaine Injectable Due to Glass Particulate
Pharmedium Services, LLC is recalling specific lots of compounded Fentanyl Citrate and Bupivacaine HCl injectable solutions because they were produced using an API contaminated with glass particulate matter.
Product
10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1411-2016·2016-07-27
FDA Recalls Hydrocodone and Bupivacaine Cassettes Due to Glass Particulates
Pharmedium Services is recalling 212 cassettes of compounded hydrocodone and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.
Product
20 mcg/mL HYDROmorphone HCl and 0.1% 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 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-2
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
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, LLC
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1412-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter
PharMEDium Services, LLC is recalling 555 sterile injectable drug cassettes containing Hydromorphone HCl and Bupivacaine HCl due to the presence of glass particulate matter.
Product
20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1430-2016·2016-07-27
PharMEDium Recalls Sterile Injectable Drugs Contaminated With Glass Particulate
PharMEDium Services is recalling 90 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.
Product
5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54
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
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-1246-2016·2016-07-20
Medaus Recalls Thiamine Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Thiamine 100 mg/mL vials because the company cannot assure the sterility of the product. The recall covers lots distributed in the U.S., Japan, and New Zealand.
Product
THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY
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-1240-2016·2016-07-20
Medaus Recalls Taurine Vials Due to Lack of Sterility Assurance
Medaus, Inc. is recalling Taurine 50 mg/mL vials because the company cannot assure the product is sterile.
Product
TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
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-1327-2016·2016-07-20
Pharmakon Recalls Phenylephrine Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 800 syringes of Phenylephrine HCI 100mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1211-216·2016-07-20
Medaus Recalls Magnesium Chloride Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Magnesium Chloride 200mg/mL vials because the company cannot assure the sterility of the product.
Product
MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1193-2016·2016-07-20
Medaus Recalls Hydroxy B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific vials of Hydroxy B12 injection due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.
Product
HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1267-2016·2016-07-20
Pharmakon Recalls Midazolam Syringes Due to Sterility Assurance Concerns
Pharmakon Pharmaceuticals is recalling 40 vials of compounded Midazolam (PF) 5mg/ml 25 mL BD syringes due to a lack of assurance of sterility.
Product
Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67
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-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-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-1238-2016·2016-07-20
Medaus Recalls Selenium Vials Due to Lack of Sterility Assurance
Medaus, Inc. is recalling specific lots of Selenium 200mcg/mL vials because the company cannot ensure the product is sterile.
Product
SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide

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7401–7425 of 11856