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

2651–2675 of 5063

ModerateFDA (Drugs)·D-0578-2023·2023-05-24
Pyrazinamide 500 mg Tablets Recalled for Quality Program Discontinuation
RemedyRepack Inc. is recalling Pyrazinamide 500 mg tablets because the original manufacturer discontinued the quality assurance program that would ensure the product meets identity, strength, quality, and purity standards.
Product
Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0567-2023·2023-05-17
Atovaquone Oral Suspension Recalled for Bacillus cereus Contamination
Camber Pharmaceuticals is recalling Atovaquone Oral Suspension due to contamination by Bacillus cereus bacteria. The contamination was discovered during testing of repackaged medication.
Product
ATOVAQUONE — ATOVAQUONE (ATOVAQUONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0570-2023·2023-05-17
Gabapentin tablets recalled due to product mixup with foreign tablet
The Harvard Drug Group recalled 3,984 cartons of Gabapentin 600 mg tablets distributed nationwide due to a product mixup where one foreign tablet was found.
Product
GABAPENTIN — GABAPENTIN (GABAPENTIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0568-2023·2023-05-17
Calcitonin Salmon Nasal Spray Recalled for Glass Particle Defect
Apotex Corp. recalls Calcitonin Salmon nasal spray (82,375 bottles) nationwide due to a glass splinter entrapped in the pump mechanism. The defect renders the nasal spray inoperable.
Product
CALCITONIN SALMON — CALCITONIN SALMON (CALCITONIN SALMON)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0572-2023·2023-05-10
NUX Male Enhancement Capsules Recalled for Undeclared Prescription Ingredients
The FDA recalls NUX Male Enhancement capsules distributed nationwide because they contain undeclared sildenafil and tadalafil, making them an unapproved drug. Consumers should not use this product.
Product
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0573-2023·2023-05-10
Unapproved Drug Capsule Recalled for Undeclared Sexual Enhancement Ingredients
DYNAMITE SUPER capsule is being recalled nationwide because it was marketed without FDA approval and contains undeclared sildenafil and tadalafil, active ingredients used in sexual enhancement products.
Product
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0571-2023·2023-05-10
Pro Power Knight Plus Capsule Recalled for Undeclared Pharmaceutical Ingredients
Pro Power Knight Plus capsules contain undeclared sildenafil and tadalafil, prescription ingredients not listed on the label. The product was marketed as an unapproved drug and poses safety risks.
Product
Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0564-2023·2023-05-10
Advil Ibuprofen 200mg tablets recalled due to improper storage conditions
Family Dollar Stores is recalling Advil Ibuprofen 200mg caplets stored outside temperature requirements. The recall affects units distributed nationwide from July 2022 through March 2023.
Product
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0566-2023·2023-05-10
Advil Liqui-Gels 200 mg ibuprofen capsules recalled for improper storage
Family Dollar Stores is recalling Advil Liqui-Gels 200 mg ibuprofen capsules (SKUs 0999841 and 0916071) distributed nationwide due to storage outside labeled temperature requirements.
Product
Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0560-2023·2023-05-10
Drug recall: Simvastatin 20 mg due to manufacturing control deviations
PD-Rx Pharmaceuticals is voluntarily recalling 520 bottles of Simvastatin USP 20 mg nationwide due to manufacturing process quality control deviations. No adverse events have been reported.
Product
Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0562-2023·2023-05-10
Seatex Alcohol Antiseptic 80% Hand Sanitizer Recalled for Superpotency and Impurities
Seatex Alcohol Antiseptic 80% (1-gallon containers) is being recalled because the formula does not meet specifications, with superpotency and impurities present. The recall affects lot 220888 distributed in Florida, Georgia, and Texas.
Product
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-0561-2023·2023-05-10
Simvastatin 40 mg recalled nationwide for manufacturing quality deviations
PD-Rx Pharmaceuticals voluntarily recalled Simvastatin 40 mg due to manufacturing quality issues. The recall affects 393 bottles distributed nationwide, with affected lot expiration dates ranging from May 2023 to April 2024.
Product
Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0557-2023·2023-05-10
Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations
PD-Rx Pharmaceuticals has recalled 352 bottles of Montelukast Sodium USP 10 mg tablets distributed nationwide due to manufacturing process deviations. This was a voluntary recall by the firm.
Product
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0559-2023·2023-05-10
Drug Recall: Glimepiride 4 mg for Manufacturing Practice Deviations
PD-Rx Pharmaceuticals is recalling 186 bottles of Glimepiride USP 4 mg due to manufacturing deviations. Patients using this medication should contact their healthcare provider to verify if their supply is affected.
Product
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0558-2023·2023-05-10
Simvastatin USP Tablets Recalled Due to Manufacturing Quality Deviations
PD-Rx Pharmaceuticals is recalling Simvastatin USP 10 mg tablets due to manufacturing quality deviations. The recall affects 37 bottles distributed nationwide.
Product
Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0565-2023·2023-05-10
Advil Dual Action Pain Reliever Recalled for Storage Temperature Deviation
Family Dollar Stores is recalling Advil Dual Action pain reliever tablets (36-caplet bottles, SKU 0902867) nationwide because the product was stored outside labeled temperature requirements.
Product
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0563-2023·2023-05-10
Advil Ibuprofen Tablets Recalled for Storage Temperature Deviation
Family Dollar Stores is recalling Advil Ibuprofen 200 mg tablets due to a storage temperature deviation during manufacturing and distribution. No illnesses have been reported.
Product
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0556-2023·2023-05-10
Lidocaine Patch 5% Recalled for Typographical Error on Label
Bryant Ranch Prepack is recalling Lidocaine Patch 5% nationwide due to a typographical error on product labels. The labels incorrectly state 'tablet' instead of 'patch', creating potential confusion about the dosage form.
Product
LIDOCAINE — LIDOCAINE (LIDOCAINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0542-2023·2023-05-03
Dianeal Low Calcium Dialysis Solution Recalled for Potential Sterility Loss
Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution nationwide due to potential leaks from the container that could compromise sterility. Affected patients should contact their healthcare provider.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0569-2023·2023-05-03
Fyremadel Ganirelix Acetate Injection Recalled for Glass Contamination
Sun Pharmaceutical is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection due to glass contamination found in a unit from lot HAD1190A. The recall affects units distributed nationwide with expiration 02/2024.
Product
FYREMADEL — FYREMADEL (GANIRELIX ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0554-2023·2023-05-03
Tadalafil Tablets Recalled Due to Manufacturing Practice Violations
Northwind Pharmaceuticals is recalling 23 bottles of Tadalafil 5 mg tablets nationwide due to manufacturing process deviations. The FDA classified this as a Class II recall.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0543-2023·2023-05-03
Peritoneal dialysis solution recalled due to sterility assurance concerns
Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks in the Luer component. The recall affects Lot Y405201 distributed nationwide in the United States.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0550-2023·2023-05-03
Prescription drug recall for manufacturing quality control deviations
Northwind Pharmaceuticals is recalling 33 bottles of Doxazosin 4mg tablets due to manufacturing quality control deviations. No illnesses or injuries have been reported.
Product
DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0552-2023·2023-05-03
Prescription Drug Glimepiride Tablets Recalled Due to Manufacturing Deviations
Northwind Pharmaceuticals recalls specific lots of Glimepiride 4mg tablets due to manufacturing practice deviations. Affected tablets were distributed nationwide.
Product
GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0551-2023·2023-05-03
FDA Recalls Glimepiride Tablets for Manufacturing Deviations
Northwind Pharmaceuticals is voluntarily recalling Glimepiride 2mg tablets distributed nationwide due to Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
Product
GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
Category
Drug
Distribution
Distributed nationwide

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2651–2675 of 5063