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

5051–5075 of 8589

SevereFDA (Drugs)·D-0614-2016·2016-02-03
Sentara Parenteral Amino Acid Infusion Recalled for Sterility Concerns
Sentara Enterprises is recalling Parenteral Amino Acid Infusion 10% bags because product sterility cannot be guaranteed. The recall affects specific lots compounded in September 2015.
Product
Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l)
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0640-2016·2016-02-03
Sentara Recalls Solu-Cortef Syringes Due to Sterility Concerns
Sentara Enterprises is recalling 9 bags of Solu-Cortef (hydrocortisone) 1MG in NS syringes because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.
Product
Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0620-2016·2016-02-03
Sentara Recalls Dextrose-NaCl Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Dextrose-NaCl (D5-1/2NS) in Homepumps because product sterility cannot be guaranteed.
Product
Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0598-2016·2016-02-03
Pharmakon Recalls Hydromorphone Syringes Due to Stability Data Issues
Pharmakon Pharmaceuticals is recalling 8,000 units of Hydromorphone HCl 1 mg/mL syringes nationwide because stability data does not support the expiration dates.
Product
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0637-2016·2016-02-03
Sentara Recalls Compounded Cancidas Due to Sterility Concerns
Sentara Enterprises is recalling 7 bags of compounded Cancidas (caspofungin acetate) because the sterility of the product cannot be guaranteed.
Product
Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0641-2016·2016-02-03
Sentara Recalls Gentamicin Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Gentamicin Homepumps because the sterility of the product cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
Product
GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0618-2016·2016-02-03
Sentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues
Sentara Enterprises is recalling specific lots of Intralipid fat emulsion because the product's sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.
Product
INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0642-2016·2016-02-03
Sentara Recalls Tobramycin Homepumps Due to Sterility Concerns
Sentara Enterprises is recalling Tobramycin 120MG Homepumps because the sterility of the product cannot be guaranteed. The affected lots were compounded in September 2015.
Product
Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0635-2016·2016-02-03
Sentara Recalls Nafcillin Bags Due to Sterility Assurance Concerns
Sentara Enterprises is recalling 28 bags of Nafcillin 2GM in NS due to a lack of assurance of sterility. The affected product was distributed in Virginia and North Carolina.
Product
Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0631-2016·2016-02-03
Sentara Recalls Morphine Infusion Bags Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Morphine 10mg/ml in NS infusion bags because the sterility of the product cannot be guaranteed.
Product
MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0634-2016·2016-02-03
Sentara Recalls Ampicillin/Sulbactam Bags Due to Sterility Concerns
Sentara Enterprises is recalling 9 bags of Ampicillin/Sulbactam 12GM in NS due to a lack of assurance of sterility. The affected products were distributed in Virginia and North Carolina.
Product
Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0619-2016·2016-02-03
Sentara Recalls Potassium Chloride Infusions Due to Sterility Concerns
Sentara Enterprises is recalling specific lots of Potassium Chloride in D 5 1/2NS home infusion bags because sterility cannot be guaranteed.
Product
POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0575-2016·2016-01-27
FDA Recalls Energique Homeopathic Skin Spray Due to Microbial Contamination
Grato Holdings, Inc. is recalling 118 bottles of Energique homeopathic skin spray due to out-of-specification microbial counts.
Product
Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0581-2016·2016-01-27
Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Particulates
Pine Pharmaceuticals is recalling Bevacizumab syringes for intravitreal use because they contain silicone oil microdroplets.
Product
Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0582-2016·2016-01-27
Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Microdroplets
Pine Pharmaceuticals is recalling specific lots of bevacizumab syringes for intravitreal use due to the presence of silicone oil microdroplets.
Product
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0580-2016·2016-01-27
FDA Recalls Energique Homeopathic Pain Spray for Microbial Contamination
Grato Holdings is recalling Energique First Aid Pain & Trauma Relief homeopathic spray due to out-of-specification microbial counts.
Product
Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0577-2016·2016-01-27
Energique Joint Pain Spray Recalled for Microbial Contamination
Grato Holdings is recalling Energique Joint Pain & Stiffness Relief Topical Spray due to microbial contamination. Testing revealed out-of-specification results for total aerobic microbiological count.
Product
Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Di
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0584-2016·2016-01-27
Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Particulates
Pine Pharmaceuticals is recalling specific lots of bevacizumab syringes for intravitreal injection because they contain silicone oil microdroplets.
Product
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0569-2016·2016-01-27
Amerita Recalls Baclofen Syringes Due to Sterility Assurance Concerns
Amerita Specialty Infusion Services is recalling specific lots of compounded Baclofen syringes because the FDA identified a lack of assurance of sterility.
Product
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0585-2016·2016-01-27
Mylan Bromfenac Ophthalmic Solution Recalled for Sterility Assurance Failure
Mylan Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because the preservative failed an effectiveness test, raising concerns about sterility.
Product
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0570-2016·2016-01-27
Amerita Recalls Baclofen and Clonidine Syringes Due to Sterility Concerns
Amerita Specialty Infusion Services is recalling specific lots of compounded intrathecal syringes because the company cannot ensure they are sterile.
Product
IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0549-2016·2016-01-06
Gentamicin Syringes Recalled for Lack of Sterility Assurance
Walgreens Infusion Services is recalling 27 prefilled Gentamicin syringes in Texas due to a lack of assurance of sterility.
Product
Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0537-2016·2016-01-06
Walgreens Recalls Oxacillin Infusion Bags Due to Sterility Concerns
Walgreens Infusion Services is recalling 14 bags of compounded Oxacillin 12 g/NS 270 mL due to a lack of assurance of sterility. The product was distributed in Texas.
Product
Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0556-2016·2016-01-06
Walgreens Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
Walgreens Infusion Services is recalling 43 bags of 0.9% Sodium Chloride injection in Texas due to a lack of assurance of sterility.
Product
0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0552-2016·2016-01-06
Remicade Injection Recalled for Lack of Sterility Assurance
Walgreens Infusion Services is recalling Remicade (Infliximab) injection bags in Texas due to a lack of assurance of sterility.
Product
Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Category
Drug
Distribution
1 state

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5051–5075 of 8589