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

1401–1425 of 11852

HighFDA (Drugs)·D-1152-2023·2023-09-27
TRP Natural Eyes Sterile Eye Drops Recalled Due to Sterility Assurance
TRP Natural Eyes Allergy Eyes Relief Sterile Eye Drops (NDC 17312-032-15, Lot IY001) are recalled due to lack of assurance of sterility. Approximately 8,747 units distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Allergy Eyes 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: 17312-032-15.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1157-2023·2023-09-27
Sterile Eye Drops Recalled for Lack of Sterility Assurance TRP Natural Eyes
TRP Natural Eyes sterile eye drops have been recalled because their sterility cannot be confirmed. About 8,000 units distributed to medical accounts in Rhode Island and Colorado are affected.
Product
TRP Natural Eyes, Eye Lid 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: 17312-417-19.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1167-2023·2023-09-27
octiq Lubricating Eye Drops Recalled Due to Sterility Assurance Defect
Innovus Pharmaceuticals recalled octiq Lubricating Eye Drops due to lack of assurance of sterility. The affected lot was distributed to accounts in Rhode Island and Colorado.
Product
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-1156-2023·2023-09-27
FDA Recalls TRP Natural Eyes Eye Drops for Sterility Concerns
FDA is recalling TRP Natural Eyes Dryness Relief eye drops due to lack of assurance of sterility. Approximately 83,898 units were distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Dryness 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: 17312-096-19.
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-1163-2023·2023-09-27
TRP Natural Eyes Red Eye Relief Recalled for Sterility Failure
TRP Natural Eyes Red Eye Relief sterile eye drops have been recalled due to lack of assurance of sterility. The recall affects 8,868 units distributed to accounts in Rhode Island and Colorado.
Product
TRP Natural Eyes, Red Eye 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: 17312-058-15.
Category
Drug
Distribution
2 states
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-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-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
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
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-1120-2023·2023-09-06
Neonatal Injectable Nutrition Bags Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 132 bags of neonatal injectable nutrition due to unvalidated sterilization processes. The lack of sterility assurance creates potential infection risk for neonatal patients receiving these products.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1140-2023·2023-09-06
DIANEAL Low Calcium peritoneal dialysis solution recalled for potential sterility compromise
Baxter Healthcare is recalling DIANEAL Low Calcium With Dextrose peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The FDA classified this as a Class II recall.
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-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-1114-2023·2023-09-06
Neonatal TPN Starter Bag recalled for sterility assurance concerns
Central Admixture Pharmacy Services is recalling a neonatal TPN bag due to lack of validated sanitation cycles, affecting 84 units distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1109-2023·2023-09-06
Cardioplegia Solution Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot #36-262515) due to lack of validation data for sanitization cycles, creating uncertainty about sterility standards for this injectable product.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1129-2023·2023-09-06
FDA Recalls EPINEPHrine IV Bags for Unvalidated Sterilization Processes
Central Admixture Pharmacy Services is recalling 340 bags of epinephrine IV solution due to inadequate validation of sterilization procedures, creating a potential contamination risk.
Product
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1133-2023·2023-09-06
Injectable Oxytocin Recalled Due to Unvalidated Sterilization Process
Central Admixture Pharmacy Services recalls oxytocin IV bags due to inadequate validation of sterilization, raising sterility concerns for this injectable.
Product
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1134-2023·2023-09-06
OxyTOCIN IV Bags Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 298 bags of oxyTOCIN 40 units IV bags nationwide due to lack of validation data for sanitization cycles, creating potential sterility concerns.
Product
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1107-2023·2023-09-06
FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 304 bags of cardioplegia solution nationwide due to lack of validation data for sterilization cycles.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide

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1401–1425 of 11852