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

14351–14375 of 31492

HighFDA (Drugs)·D-0414-2024·2024-04-03
Phenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
SCA Pharmaceuticals is recalling Phenylephrine HCl injections nationwide affecting approximately 33,000 units due to lack of assurance of sterility.
Product
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1365-2024·2024-04-03
Thermalon Stye Compress recalled due to potential mold and mildew
Bruder Healthcare Company is recalling Thermalon Stye Compress (Item Number 24352) in certain lots due to potential mold and mildew growth from excessive moisture exposure. No illnesses have been reported.
Product
Thermalon Stye Compress, Item Number 24352
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1094-2024·2024-04-03
Himalayan Pain Relief Tea Contains Undeclared Pharmaceutical Drugs
WS Global Inc is recalling Himalayan Pain Relief Tea nationwide due to undeclared pharmaceutical drugs—Diclofenac and Dexamethasone Acetate—that were not listed on the product label.
Product
Himalayan Pain Relief Tea for Gout and Hangover
Category
Food
Distribution
Distributed nationwide
HighNHTSA·24V174000·2024-04-03
2023 NOVA BUS LFS recall—missing electrical components for battery switch
Certain 2022-2023 NOVA BUS LFS vehicles may have missing electrical components that prevent the battery disconnect switch from functioning properly, creating a risk of electrical shock during maintenance.
Product
NOVA BUS — 2023 NOVA BUS LFS
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0394-2024·2024-04-03
Diltiazem HCl Injection Lacks Sterility Assurance; SCA Pharmaceuticals Recalls
SCA Pharmaceuticals is recalling Diltiazem HCl 125 mg Injectable (381 bags) due to lack of sterility assurance. Patients and healthcare providers should not use affected units from lot #1223049625.
Product
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0405-2024·2024-04-03
HYDROmorphone Injection Syringes Recalled for Sterility Assurance Issue
SCA Pharmaceuticals is recalling HYDROmorphone HCl injection syringes due to lack of assurance of sterility. The recall affects 5,734 syringes distributed nationwide.
Product
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0402-2024·2024-04-03
fentaNYL 1,250 mcg Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling fentaNYL 1,250 mcg/25 mL injection syringes due to lack of sterility assurance. The nationwide recall affects 1,259 syringes; patients should contact their healthcare provider.
Product
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0415-2024·2024-04-03
Phenylephrine Injectable Drug Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling phenylephrine HCl injection syringes nationwide due to inability to assure sterility. Patients using recalled lots should contact their healthcare provider.
Product
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1394-2024·2024-04-03
IV Start Kit Recalled Due to Supplier Saline Syringe Issue
Medical Action Industries is recalling 206,200 IV Start Kits due to saline syringes recalled by the supplier. The affected kits were distributed in Minnesota and North Dakota.
Product
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0421-2024·2024-04-03
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling Phenylephrine HCl 800 mcg/10 mL injections due to lack of assurance that the product is sterile. The recall affects 2,427 syringes distributed nationwide.
Product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID f
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0403-2024·2024-04-03
Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl injection syringes due to concerns about sterility. No illnesses have been reported, but patients and healthcare providers should check if they have products from the affected lot numbers, which expired in December 2023.
Product
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0426-2024·2024-04-03
Divalproex Sodium 250 mg tablets recalled for failed dissolution specifications
Amneal Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets 250 mg nationwide due to failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.
Product
DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0406-2024·2024-04-03
HYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
SCA Pharmaceuticals is recalling 1,425 syringes of HYDROmorphone HCl 6 mg/30 mL due to lack of assurance of product sterility. The affected lots were distributed nationwide.
Product
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0425-2024·2024-04-03
Vancomycin Injectable Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling 368 bags of vancomycin 1.25 g injectable nationwide because the company cannot assure sterility was maintained. The affected lot was distributed across the USA.
Product
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1359-2024·2024-04-03
Thermalon Eye Compress Recalled Due to Potential Mold and Mildew Growth
Bruder Healthcare Company is recalling Thermalon Eye Compress Item 2434 from certain lots due to potential mold and mildew growth from excessive moisture exposure. Affected products were distributed in the US and Canada.
Product
Thermalon Eye Compress, Item Number 2434
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0404-2024·2024-04-03
FDA Recalls HYDROmorphone Injection Cassettes Due to Sterility Concerns
SCA Pharmaceuticals recalls 256 units of HYDROmorphone HCl injection in Grey CADD Cassettes nationwide due to lack of assured sterility. The affected lot is #1223049529 with expiration date 01/03/24.
Product
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1109-2024·2024-04-03
Nordic Naturals Baby Vitamin D3 Liquid Recalled for Elevated Levels
Nordic Naturals has recalled its Baby's Vitamin D3 dietary supplement liquid due to elevated vitamin D3 levels. The recall affects approximately 5,564 bottles with lot number 234909.
Product
Nordic Naturals Baby s Vitamin D3 liquid, 400 IU (10 mcg) D3, 0.76 fl oz (22.5 mL) DIETARY SUPPLEMENT, dark glass bottle
Category
Drug
Distribution
28 states
HighFDA (Drugs)·D-0396-2024·2024-04-03
Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl 2,500 mcg injection due to lack of sterility assurance. Affected batches were distributed nationwide.
Product
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1396-2024·2024-04-03
Certain OptiCross Coronary Imaging Catheters recalled for manufacturing defect
Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.
Product
OptiCross Coronary Imaging Catheter, REF H749518080120
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1379-2024·2024-04-03
Baxter Peri-Guard Repair Patch Contraindication Added for Neurosurgery
Baxter Healthcare has added a contraindication to Peri-Guard Repair Patch instructions, restricting use in neurosurgery because endotoxin levels may exceed allowable limits for cerebrospinal fluid-contacting devices.
Product
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1364-2024·2024-04-03
Thermalon Heating Pads Recalled for Potential Mold and Mildew Growth
Bruder Healthcare recalls Thermalon Heating Pad model 24002 due to potential mold and mildew growth from moisture exposure. Affected units were distributed nationwide in the US and to Canada.
Product
Thermalon Heating Pad, Item Number 24002
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1386-2024·2024-04-03
Philips Patient Information Center Custom Ringtones Fail When Screen Locked
Philips Patient Information Center iX running software version 4.X may not play custom ringtones when iOS screens are locked with a passcode. Approximately 257,183 units have been distributed worldwide. No injuries have been reported.
Product
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1125-2024·2024-04-03
Dietary Supplement Recall: TestoFREAK Contains Sub-Potent Zinc Levels
VRA Formulations is recalling TestoFREAK Maximize Testosterone Dietary Supplement due to sub-potent zinc content. Affected bottles were distributed domestically through internet sales.
Product
TestoFREAK Maximize Testosterone Dietary Supplement 60 capsules per dark amber bottle, 100 bottles per case
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-1097-2024·2024-04-03
Bluebonnet Methylfolate Chewables Recalled for Label Unit Error
Bluebonnet Nutrition is recalling EarthSweet Chewables CellularActive Methylfolate 1000 mcg due to a labeling error stating '1000 mg' instead of '1000 mcg' on the front label.
Product
EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets packaged in an amber glass botte with purple lid
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-1106-2024·2024-04-03
Food Recall: German Home Bakery Poppy Coffee Cake for Undeclared Yellow #5
NRS Enterprises, Inc. (Sunflour Bakery) recalled 197 loaves of German Home Bakery Poppy Coffee Cake due to undeclared Yellow #5 dye. The product was distributed in California.
Product
German Home Bakery Poppy Coffee Cake, 16 oz, clear poly bag
Category
Food
Distribution
1 state

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14351–14375 of 31492