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

7476–7500 of 11823

SevereFDA (Drugs)·D-1201-2016·2016-07-20
Medaus Recalls Lipo with Lidocaine Vials Due to Sterility Concerns
Medaus, Inc. is recalling Lipo with Lidocaine #3 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 W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1306-2016·2016-07-20
Pharmakon Recalls Fentanyl and Ropivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 50 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1239-2016·2016-07-20
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 (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1340-2016·2016-07-20
Pharmakon Recalls Vecuronium Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 275 vials of compounded Vecuronium 1mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Product
Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0972-72
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-1251-2016·2016-07-20
Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Zinc Sulfate 10mg/mL vials because the company cannot guarantee the product is sterile.
Product
ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1207-2016·2016-07-20
Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the company cannot ensure the product is sterile.
Product
LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
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-1209-2016·2016-07-20
Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the company cannot guarantee the product is sterile.
Product
LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG,INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/ML, 5ML 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
SevereFDA (Drugs)·D-1319-2016·2016-07-20
Pharmakon Recalls Fentanyl and Bupivacaine Bags Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 870 bags of compounded Fentanyl and Bupivacaine due to a lack of assurance of sterility.
Product
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1256-2016·2016-07-20
Pharmakon Recalls Phenylephrine Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling Phenylephrine 40 mcg/mL injection syringes due to a lack of assurance of sterility.
Product
Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0011-72
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1233-2016·2016-07-20
Medaus Recalls Proline 100mg/mL Vials Due to Sterility Concerns
Medaus, Inc. is recalling Proline 100mg/mL vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Product
PROLINE 100MG/ML (PF), 5ML 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-1253-2016·2016-07-20
Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Zinc Sulfate 1mg/mL vials because the company cannot ensure the product is sterile.
Product
ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1174-2016·2016-07-20
Medaus Recalls B-Complex Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of B-Complex with Cyanocobalamin vials because the company cannot ensure the product is sterile.
Product
B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5MLVials, c) 10ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1178-2016·2016-07-20
Medaus Recalls Dexpantenol Vials Due to Sterility Concerns
Medaus, Inc. is recalling Dexpantenol 250mg/mL vials because the company cannot ensure the product is sterile.
Product
DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1237-2016·2016-07-20
Medaus Recalls Riboflamin Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling specific lots of Riboflavin 10mg/mL vials because the company cannot ensure the product is sterile.
Product
RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1172-2016·2016-07-20
Medaus Recalls B-Complex 50 Vials Due to Sterility Concerns
Medaus, Inc. is recalling B-Complex 50 in NaCl 0.9% vials because the company cannot assure the sterility of the product.
Product
B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML 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
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

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7476–7500 of 11823