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

1651–1675 of 18005

HighFDA (Drugs)·D-0549-2024·2024-06-19
Phenazopyridine bottles recalled due to medication mix-up error
RemedyRepack Inc. is recalling bottles labeled as Phenazopyridine HCl 100mg that actually contain Phenobarbital 16.2mg tablets. Eight bottles were distributed to one medical facility. Patients should not use these medications and must contact their healthcare provider.
Product
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0545-2024·2024-06-19
Prescription Drug Recall: Phenazopyridine Tablets Contain Wrong Medication
Winder Laboratories is recalling Phenazopyridine HCl tablets (Lot #1142404) due to a product mix-up where some bottles contain Phenobarbital tablets instead. No illnesses or injuries have been reported.
Product
PHENAZOPYRIDINE HYDROCHLORIDE — PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0548-2024·2024-06-19
FDA Recalls Eye Suspension Medication for Lack of Sterility Assurance
Imprimis NJOF, LLC is recalling one lot of a compounded ophthalmic suspension due to failure of sterility assurance. The product may be contaminated and pose a risk of serious eye infection.
Product
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0546-2024·2024-06-19
Zilretta Injectable Drug Recalled for Failed Stability Specifications
Pacira Pharmaceuticals is recalling 43,768 kits of Zilretta injectable suspension due to failed stability specifications at 2–8°C storage for 12 months followed by 25°C for 6 weeks. No illnesses or injuries have been reported.
Product
ZILRETTA — ZILRETTA (TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0547-2024·2024-06-19
Klarity-C Ophthalmic Emulsion Recalled Due to Sterility Assurance Risk
Imprimis is recalling Klarity-C, a cyclosporine eye medication, because the company cannot assure the product meets sterility standards. Approximately 136,005 units were distributed nationwide.
Product
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0552-2024·2024-06-19
Asmanex Twisthaler inhalation powder recalled due to defective container
Organon LLC is recalling Asmanex Twisthaler (mometasone furoate) inhalation powder nationwide due to defective containers. Affected lot #Y000085 expires April 25, 2025.
Product
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0550-2024·2024-06-19
Asmanex (Mometasone Furoate) Recalled Due to Defective Container
Organon LLC has voluntarily recalled 2,886 units of Asmanex inhalation powder nationwide due to defective containers.
Product
ASMANEX — ASMANEX (MOMETASONE FUROATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0551-2024·2024-06-19
ASMANEX Inhalation Powder Recalled Due to Defective Container
Organon LLC is recalling 2,551 units of ASMANEX Twisthaler mometasone furoate inhalation powder nationwide due to defective containers. Affected lot X024051 expires April 25, 2025.
Product
ASMANEX — ASMANEX (MOMETASONE FUROATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0534-2024·2024-06-12
Prescription migraine drug recalled for manufacturing impurity above FDA limit
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons distributed nationwide.
Product
RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0535-2024·2024-06-12
FDA Recalls Rizatriptan Benzoate Tablets for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate 10mg tablets nationwide due to N-nitroso impurity levels exceeding FDA acceptable limits, affecting 13,296 cartons.
Product
RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0533-2024·2024-06-12
Rizatriptan Benzoate Tablets Recalled for Excessive N-Nitroso Impurity
Glenmark Pharmaceuticals recalls certain Rizatriptan Benzoate tablets due to N-Nitroso Desmethyl Rizatriptan impurity levels exceeding FDA acceptable limits. The affected lots were distributed nationwide.
Product
RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0532-2024·2024-06-12
Prescription Rizatriptan Benzoate Tablets Recalled for Chemical Impurity
Glenmark Pharmaceuticals recalls Rizatriptan Benzoate 5mg tablets due to excess N-Nitroso Desmethyl Rizatriptan impurity. The nationwide recall affects 3,480 cartons with lots 19233788 and 19224445.
Product
RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0540-2024·2024-06-12
Cephalexin oral suspension recalled for incorrect dose labeling
Bryant Ranch Prepack is recalling 61 bottles of Cephalexin for Oral Suspension due to a back label stating an incorrect dose amount—5g instead of 10g per bottle.
Product
CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0541-2024·2024-06-12
Pregabalin Capsules Recalled Due to Foreign Tablet Contamination During Packaging
Rising Pharma's pregabalin capsules are being recalled nationwide after a pantoprazole tablet was discovered during packaging. No illnesses have been reported.
Product
PREGABALIN — PREGABALIN (PREGABALIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0543-2024·2024-06-12
Estradiol transdermal patches recalled for failed quality specifications
Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.
Product
ESTRADIOL — ESTRADIOL (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0544-2024·2024-06-12
TIVICAY HIV medication carton mislabeled with incorrect expiration date
GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.
Product
TIVICAY — TIVICAY (DOLUTEGRAVIR SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0538-2024·2024-06-12
Cephalexin Oral Suspension Recalled for Incorrect Dosage Label
Bryant Ranch Prepack is recalling Cephalexin oral suspension because the back label incorrectly states the bottle contains 5g instead of 10g. No illnesses have been reported.
Product
CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0542-2024·2024-06-12
Estradiol Transdermal Patch Recalled for Failed Chemical Specifications
Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.
Product
ESTRADIOL — ESTRADIOL (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0537-2024·2024-06-12
Cephalexin oral suspension recalled for incorrect label dosage amount
Bryant Ranch Prepack is recalling Cephalexin oral suspension (125mg/5mL) due to back label errors stating the dose as 2.5g instead of the correct 5g per bottle. No illnesses have been reported.
Product
CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0536-2024·2024-06-12
Cephalexin Oral Suspension Recalled for Incorrect Labeling and Missing Dosage Information
Bryant Ranch Prepack is recalling Cephalexin oral suspension bottles due to incorrect labeling that states tablet information instead of liquid suspension details and omits the total dose per bottle.
Product
CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0539-2024·2024-06-12
Cephalexin for Oral Suspension Recalled for Back Label Error
Cephalexin for Oral Suspension is being recalled due to a back label error. The label states 'Each contains' instead of 'Each Bottle contains,' affecting 190 bottles distributed nationwide.
Product
CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0511-2024·2024-06-05
Compounded Tirzepatide Vials Mislabeled with Testosterone Cypionate
Revive Rx Pharmacy recalls 751 vials of compounded tirzepatide (Lot #748127) labeled to contain tirzepatide but actually filled with testosterone cypionate. Patients receiving this medication may take the wrong drug with serious health consequences.
Product
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0512-2024·2024-06-05
Epinephrine-Lidocaine Intraocular Injection Vials Recalled for Sterility Assurance
Imprimis NJOF, LLC is recalling 14,180 vials of Epinephrine-Lidocaine intraocular injection due to lack of assurance of sterility. These vials were distributed nationwide within the United States.
Product
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0518-2024·2024-06-05
Cefdinir Oral Suspension recalled nationwide for defective container seals
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to defective container seals. The recall affects 51,006 bottles distributed nationwide with lot numbers F305184, F305185, and F305186.
Product
CEFDINIR — CEFDINIR (CEFDINIR)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0509-2024·2024-06-05
Cathflo Activase Injection Vials Recalled Due to Deformed Stoppers
Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.
Product
CATHFLO ACTIVASE — CATHFLO ACTIVASE (ALTEPLASE)
Category
Drug
Distribution
Distributed nationwide

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1651–1675 of 18005