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

2051–2075 of 5047

HighFDA (Drugs)·D-1162-2023·2023-09-27
TRP Natural Eyes Pink Eye Relief drops recalled for sterility assurance issues
TRP Natural Eyes Pink Eye Relief sterile eye drops (Lot FP001, expires 07/24) are being recalled due to lack of assurance of sterility. Consumers with this product should stop using it and consult their healthcare provider.
Product
TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1153-2023·2023-09-27
TRP Natural Eyes sterile eye drops recalled due to lack of sterility assurance
AMMAN PHARMACEUTICAL INDUSTRIES is recalling TRP Natural Eyes Allergy Relief eye drops due to inability to assure sterility. The recalled lot includes 8,810 units distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1172-2023·2023-09-27
Cequa cyclosporine ophthalmic solution recalled nationwide for subpotency
Sun Pharmaceutical is recalling Cequa (cyclosporine) ophthalmic solution because certain lots contain less active ingredient than specified. Contact your doctor if using an affected product.
Product
CEQUA — CEQUA (CYCLOSPORINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1168-2023·2023-09-27
ChloraPrep One-Step Topical Applicators Recalled for Unsupported Shelf-Life Claims
BD ChloraPrep One-Step topical applicators are recalled because the 36-month shelf life is not supported by stability data; the product may develop fungal contamination beyond 12 months.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1173-2023·2023-09-27
Kroger Mint Burst Antiseptic Mouth Rinse recalled for undeclared excipients
Vi-Jon, LLC is recalling 245,904 bottles of Kroger Mint Burst Antiseptic Mouth Rinse due to incorrect or undeclared excipients. The product was distributed through a single distributor with seven distribution centers.
Product
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1180-2023·2023-09-20
WEFUN Capsules Recalled: Unapproved Drug with Undisclosed Sildenafil
WEFUN Capsules 825 mg are being recalled due to contamination with sildenafil, an undisclosed active pharmaceutical ingredient not approved for the product. Distribution was nationwide.
Product
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1148-2023·2023-09-20
Pantoprazole Sodium for Injection Recalled Due to Sterility Concern
BE Pharmaceuticals is recalling Pantoprazole Sodium for Injection nationwide due to lack of sterility assurance caused by powder discoloration and small cracks in some vials. No illnesses have been reported.
Product
PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1149-2023·2023-09-20
Prescription Drug Sucralfate Suspension Recalled for Out-of-Specification Potency
VistaPharm LLC is recalling Sucralfate Oral Suspension 1g/10mL due to out-of-specification assay results. The active ingredient concentration does not meet FDA specifications in approximately 14,400 affected bottles distributed nationwide.
Product
SUCRALFATE — SUCRALFATE (SUCRALFATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1169-2023·2023-09-13
Digoxin Tablets Nationwide Recall: Bottles Mislabeled with Incorrect Dosages
Marlex Pharmaceuticals recalls Digoxin Tablets nationwide due to a labeling error where bottles are mislabeled with incorrect dosages. Bottles labeled as 0.125mg contain 0.25mg and vice versa.
Product
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1147-2023·2023-09-13
OTC Topical Cream Cartons May Contain Mislabeled Prescription Toothpaste
Capsaicin Cream 0.025% cartons labeled as pain relief cream may contain Sodium Fluoride 1.1% prescription dental toothpaste instead. Consumers should verify product contents before use.
Product
CAPSAICIN — CAPSAICIN (CAPSAICIN)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-1170-2023·2023-09-13
Digoxin Tablets Recalled Due to Reversed Dosage Labeling
Marlex Pharmaceuticals is recalling Digoxin Tablets because bottles labeled as 0.125mg contain 0.25mg strength, and vice versa. Approximately 94 100-count bottles distributed nationwide are affected.
Product
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1144-2023·2023-09-13
Injectable drug recall: Milrinone Lactate fails impurity and degradation specifications
Milrinone Lactate Injection is recalled due to failed impurity and degradation specifications. The affected lot should not be used.
Product
MILRINONE LACTATE — MILRINONE LACTATE (MILRINONE LACTATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1143-2023·2023-09-13
Prescription Drug Recall: Nexlizet Tablets Failed Dissolution Specifications
Esperion is recalling Nexlizet (bempedoic acid and ezetimibe) tablets nationwide due to failed dissolution specifications identified during stability testing. Approximately 45,240 bottles are affected.
Product
NEXLIZET — NEXLIZET (BEMPEDOIC ACID AND EZETIMIBE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1146-2023·2023-09-13
Prescription Dental Toothpaste Recalled Due to Incorrect Carton Labeling
AvKARE is recalling Sodium Fluoride 1.1% prescription dental toothpaste because cartons are labeled as Capsaicin Cream 0.025%, though the tubes are correctly labeled. Approximately 35,184 tubes have been distributed to 19 consignees.
Product
SODIUM FLOURIDE — SODIUM FLOURIDE (SODIUM FLUORIDE)
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1145-2023·2023-09-13
Fosfomycin Tromethamine Antibiotic Recalled for Failed Stability Specifications
Ascend Laboratories is recalling Fosfomycin Tromethamine antibiotic granules nationwide due to organic impurities exceeding acceptable levels in stability testing. No illnesses have been reported.
Product
FOSFOMYCIN TROMETHAMINE — FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1150-2023·2023-09-06
Vegetal Vigra Capsules Recalled for Containing Unapproved Sildenafil
The FDA is recalling Vegetal Vigra 200mg capsules nationwide because they contain sildenafil, an active ingredient in FDA-approved medications. The product was marketed without FDA approval.
Product
Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1130-2023·2023-09-06
Epinephrine IV Bags Recalled Due to Lack of Sanitization Validation
Central Admixture Pharmacy Services is recalling epinephrine IV bags (Lot 36-260047) because sanitization processes lacked adequate validation data. The manufacturer cannot confirm the product meets sterility standards required for injectable medications.
Product
EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1116-2023·2023-09-06
Neonatal TPN IV bags recalled due to lack of sterility validation
Central Admixture Pharmacy Services is recalling 200 neonatal TPN IV bags (lots 36-262872 and 36-262873, expiring 8/27/2023) distributed nationwide due to lack of validated sanitization procedures.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1113-2023·2023-09-06
Rocuronium Injectable Drug Recalled Due to Sterility Assurance Failure
The FDA is recalling rocuronium injectable syringes due to unvalidated sterilization processes. The product was distributed nationwide.
Product
rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1110-2023·2023-09-06
Cardioplegia Solution Recalled for Unvalidated Sterilization Process
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of validated sterilization processes used during its manufacture.
Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1123-2023·2023-09-06
Cardioplegia Solution Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to lack of validation data for sanitization cycles, which cannot assure product sterility.
Product
CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1117-2023·2023-09-06
Neonatal TPN Starter Bag Recalled Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 104 neonatal TPN starter bags (Lot 36-260022) due to lack of validation data for sanitization cycles, which could compromise sterility assurance in this IV medication.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1125-2023·2023-09-06
FDA Recalls Phenylephrine IV Bags Due to Sterility Validation Concerns
Central Admixture Pharmacy Services is recalling 586 bags of phenylephrine IV solution due to lack of validation data for sterilization cycles. These bags may not meet sterility assurance requirements for intravenous use.
Product
PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1126-2023·2023-09-06
Phenylephrine IV Bags Recalled for Sterility Assurance Deficiency
Central Admixture Pharmacy Services recalls 297 bags of phenylephrine IV solution due to lack of validated sanitization procedures. The Class II recall affects nationwide distribution.
Product
PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1131-2023·2023-09-06
EPINEPHrine IV bags recalled for sterility assurance failure
Central Admixture Pharmacy Services recalled 554 bags of EPINEPHrine added to dextrose 5% IV bags nationwide due to insufficient validation of sanitization procedures, creating a lack of sterility assurance.
Product
EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

2051–2075 of 5047