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

2226–2250 of 18005

HighFDA (Drugs)·D-1159-2023·2023-09-27
TRP Natural Eyes Floaters Relief Recalled for Lack of Sterility Assurance
TRP Natural Eyes Floaters Relief sterile eye drops are being recalled because the manufacturer cannot assure the product meets sterility standards. It was distributed to two direct accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Floaters Relief, 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: 17312-098-15.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1175-2023·2023-09-27
Humanrace Suncare SPF 30 Sunscreen Recalled for Subpotent Protection
HUMANRACE is recalling Humanrace Suncare Ozone Face Protection Daily Moisturizer SPF 30 because the product does not contain the declared SPF level. Affected consumers should discontinue use immediately.
Product
Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1176-2023·2023-09-27
Sunscreen Recall: Humanrace Ozone Body Protection Cream Lacks Declared SPF
Humanrace Suncare Ozone Body Protection Cream SPF 30 does not contain the sun protection factor declared on the label. Approximately 2,942 units have been recalled.
Product
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1165-2023·2023-09-27
TRP Natural Eyes Stye Relief sterile eye ointment recalled for lack of sterility assurance
FDA is recalling TRP Natural Eyes Stye Relief sterile eye ointment due to lack of assurance of sterility. The product was distributed to two accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1158-2023·2023-09-27
TRP Natural Eyes Eye Ointment Recalled for Lack of Sterility Assurance
TRP Natural Eyes sterile eye ointment (NDC 17312-165-13, Lot 180001, EXP 01/25) is being recalled due to lack of assured sterility. The product was distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1160-2023·2023-09-27
FDA Recalls Eye Ointment Product Due to Sterility Assurance Failure
The FDA is recalling Major LubriFresh PM eye ointment due to lack of assurance of sterility. Approximately 282,564 units were distributed to accounts in Rhode Island and Colorado.
Product
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
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-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
1 state
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
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-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
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-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
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-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-1124-2023·2023-09-06
Phenylephrine Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,100 syringes of phenylephrine injectable solution due to inadequate validation of sterilization cycles. The lack of documented sterilization assurance creates potential for microbial contamination.
Product
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1112-2023·2023-09-06
Cardioplegia Solution Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 786 bags of Cardioplegia Solution del Nido Formula nationwide due to lack of validation data for sanitization cycles, which affects sterility assurance.
Product
Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmac
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1137-2023·2023-09-06
Diltiazem IV Bag Recalled Due to Lack of Sterilization Assurance
Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
Category
Drug
Distribution
Distributed nationwide

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2226–2250 of 18005