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 the agency’s own highest classification or reported deaths or serious injuries, 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

23426–23450 of 114484

HighFDA (Drugs)·D-0744-2023·2023-05-31
FDA Recalls NORepinephrine Injection Due to Sterility Concerns
Central Admixture Pharmacy Services recalled 6,414 bags of NORepinephrine injection nationwide after an FDA inspection questioned the sterility of the product. Healthcare facilities should stop using and quarantine affected lots.
Product
NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0729-2023·2023-05-31
Epinephrine Injection Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling epinephrine injection (4 mg/250 mL) following FDA inspection findings that the product's sterility cannot be assured.
Product
EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7018-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0677-2023·2023-05-31
Microplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Microplegia Solution (HIGH POTASSIUM) nationwide due to FDA inspection findings questioning sterility assurance. 79 bags affected.
Product
Microplegia Solution, HIGH POTASSIUM (100 mEq), packaged in 200 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0213-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0684-2023·2023-05-31
Neonatal TPN Starter Bag Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 71 bags of Neonatal TPN Starter Bag nationwide following an FDA inspection that questioned the product's sterility. The affected lots expire in April and May 2023.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0406-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1625-2023·2023-05-31
Incisive CT Plus imaging system recalled for potential incorrect image orientation
Philips is recalling 5 Incisive CT Plus CT X-ray systems due to potential defects that may display images with flipped or reversed orientation, risking misdiagnosis, incorrect treatment, and unnecessary radiation exposure from repeat scans.
Product
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Category
Medical Device
Distribution
4 states
HighFDA (Drugs)·D-0736-2023·2023-05-31
FDA Recalls Vancomycin Injectable Solution Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 8,252 bags of vancomycin injection nationwide after FDA inspection raised concerns about product sterility. Affected lots expire May through June 2023.
Product
vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0912-2023·2023-05-31
Country Cookie Snickerdoodle Cookies Recalled for Undeclared Milk Allergen
Country Cookie LLC is recalling Snickerdoodle Cookies because the allergen statement fails to declare milk. Consumers with milk allergies are at risk of an allergic reaction.
Product
Country Cookie Snickerdoodle Cookie, plastic wrapped
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-0952-2023·2023-05-31
Culinaria Cashew and Macadamia Mix Recalled for Label Mix-Up
Culinaria Branded Roasted & Salted Colossal Cashew & Macadamia Mix (828 cans, Lot 3033A9) is being recalled due to a label mix-up. The product was distributed in Illinois, Indiana, and Missouri.
Product
Culinaria Branded Roasted & Salted Colossal Cashew & Macadamia Mix. Net Wt 9oz (255g) UPC 0 41318-22428 3. Distributed by Schnuck Markets, Inc., St. Louis, MO 63146-6928.
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0768-2023·2023-05-31
Fentanyl Buccal Tablets 400mcg missing or incorrect package insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 400mcg due to incorrect or missing package inserts in affected cartons distributed nationwide. No illnesses have been reported.
Product
Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0759-2023·2023-05-31
Glimepiride 4 Milligram Tablets Nationwide Recalled for Manufacturing Practice Deviations
Amerisource Health Services LLC is recalling 129,849 bottles of Glimepiride Tablets, USP 4 mg nationwide due to manufacturing practice deviations identified during an FDA inspection. No illnesses have been reported.
Product
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1615-2023·2023-05-31
ViziShot 2 Aspiration Needle recalled for manufacturing angle defect
ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.
Product
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-0940-2023·2023-05-31
Dietary Supplement TruCONTROL Recalled Due to Unapproved Ingredients
TruVision Health's truCONTROL 60 Count dietary supplement is being recalled because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.
Product
truCONTROL 60 Count
Category
Food
Distribution
50 states
ModerateFDA (Food)·F-0944-2023·2023-05-31
Dietary Supplement Recall: TruWeight and Energy Gen 2+ Contains Banned Ingredients
TruVision Health is recalling TruWeight and Energy Gen 2+ because it contains DMHA and hordenine, which FDA has determined are not acceptable dietary ingredients. No illnesses have been reported.
Product
TruWeight and Energy Gen 2+ 60 Count
Category
Food
Distribution
50 states
ModerateFDA (Devices)·Z-1616-2023·2023-05-31
Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance
Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.
Product
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-0943-2023·2023-05-31
Dietary supplement recalled for containing unapproved ingredients
TruVision Health LLC is recalling truControl W/Dynamine because the product contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.
Product
truControl W/Dynamine 60 ct
Category
Food
Distribution
50 states
ModerateFDA (Devices)·Z-1479-2023·2023-05-31
Fluoroscopic imaging system may display incorrect radiation dose readings
Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.
Product
Luminos Agile Max (VE10, VF10, VF11)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1632-2023·2023-05-31
Siemens Atellica CH Toxicology Calibrator Reassignment Due to Positive Bias
Siemens Healthcare Diagnostics is reassigning Atellica CH Toxicology Calibrators due to a positive bias. The affected calibrators were distributed in the US and internationally across multiple countries.
Product
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 11099440
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0767-2023·2023-05-31
Fentanyl Buccal Tablets Recalled for Missing or Incorrect Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (200mcg) due to missing or incorrect package inserts. Patients should contact their healthcare provider if they have affected product.
Product
Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1480-2023·2023-05-31
Fluoroscopic Imaging System May Display Incorrect Radiation Dose Measurements
Siemens Luminos dRF Max fluoroscopic imaging systems may occasionally display incorrect radiation dose measurements during certain operating conditions. The manufacturer states the error does not affect diagnosis or workflow.
Product
Luminos dRF Max (VE10, VF10, VF11)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1481-2023·2023-05-31
LUMINOS Lotus Max fluoroscopic system recalled for sporadic measurement errors
LUMINOS Lotus Max fluoroscopic systems may sporadically display incorrect radiation dose measurements. The error only occurs with secondary X-ray tubes and does not affect diagnosis or workflow.
Product
LUMINOS Lotus Max (VF11)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0757-2023·2023-05-31
Nationwide Recall of Glimepiride Tablets for Manufacturing Practice Deviations
Amerisource Health Services LLC recalls 63,335 bottles of Glimepiride Tablets nationwide due to manufacturing practice deviations identified during FDA inspection.
Product
Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0770-2023·2023-05-31
Fentanyl buccal tablets recalled due to incorrect or missing package insert
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets 800mcg due to incorrect or missing package inserts. The recall affects 3,032 units distributed nationwide.
Product
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0766-2023·2023-05-31
Fentanyl Buccal Tablets recalled due to missing or incorrect package insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 100mcg due to incorrect or missing package inserts in affected cartons. Patients should verify proper labeling or contact their pharmacy.
Product
Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0769-2023·2023-05-31
Fentanyl Buccal Tablets 600mcg Recalled for Incorrect or Missing Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 600mcg due to incorrect or missing package inserts in 1,908 units distributed nationwide across multiple lot numbers.
Product
Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0756-2023·2023-05-31
Methylprednisolone Acetate Injectable Suspension recalled for NDC carton labeling error
Amneal Pharmaceuticals recalls Methylprednisolone Acetate Injectable Suspension due to incorrect NDC number on product cartons. The typographical error appears on secondary packaging only; the medication vial itself is unaffected.
Product
Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal…
Category
Drug
Distribution
Distributed nationwide

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23426–23450 of 114484