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 the agency’s own highest classification or reported deaths or serious injuries, 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

1–25 of 18082

SevereFDA (Drugs)·D-0027-2027·2026-10-14
Carolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 26/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0009-2027·2026-10-14
K.C. Pharmaceuticals Recalls Leader Ultra Lubricating Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling 163,008 cartons of Leader Ultra Lubricating Eye Drops due to a lack of assurance of sterility. The product was distributed nationwide under multiple brand names.
Product
LEADER ULTRA LUBRICATING EYE DROPS — LEADER ULTRA LUBRICATING EYE DROPS (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0024-2027·2026-10-14
FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes because processing equipment used may have compromised the product's sterility.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0026-2027·2026-10-14
Carolina Infusion Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling semaglutide/cyanocobalamin injectable products due to a lack of assurance of sterility related to formulation and processing equipment.
Product
SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0030-2027·2026-10-14
FDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 85/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0006-2027·2026-10-14
K.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling 1,327,248 cartons of dry eye relief eye drops due to a lack of assurance of sterility. The products were distributed nationwide under multiple brand names.
Product
LEADER DRY EYE RELIEF EYE DROPS — LEADER DRY EYE RELIEF EYE DROPS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0036-2027·2026-10-14
Apothecary Pharma Recalls Tirzepatide Injection Vials Due to Sterility Concerns
Apothecary Pharma LLC is recalling 22 vials of Tirzepatide Injection due to a lack of assurance of sterility. The affected product was distributed nationwide.
Product
Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0003-2027·2026-10-14
Good Sense Eye Drops Recalled for Lack of Sterility Assurance
K.C. Pharmaceuticals is recalling Good Sense Eye Drops Irritation Relief and related brands due to a lack of assurance of sterility.
Product
GOODSENSE EYE DROPS IRRITATION RELIEF — GOODSENSE EYE DROPS IRRITATION RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0008-2027·2026-10-14
K.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling multiple brands of eye drops, including Leader, Equate, and Walgreens, due to a lack of assurance of sterility.
Product
LEADER EYE DROPS REDNESS RELIEF — LEADER EYE DROPS REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0022-2027·2026-10-14
FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to processing equipment.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0002-2027·2026-10-14
K.C. Pharmaceuticals Recalls Artificial Tears Due to Sterility Concerns
K.C. Pharmaceuticals is recalling 505,896 cartons of artificial tears sold under multiple brands because the product lacks assurance of sterility.
Product
LEADER ARTIFICIAL TEARS 15 ML — LEADER ARTIFICIAL TEARS 15 ML (POLYVINYL ALCOHOL, POVIDONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0020-2027·2026-10-14
Carolina Infusion Recalls Sermorelin Acetate Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Sermorelin Acetate 1 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0028-2027·2026-10-14
Carolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling specific lots of Tirzepatide/Cyanocobalamin 64/2 mg/mL injectable because the product may lack assurance of sterility.
Product
TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0018-2027·2026-10-14
Carolina Infusion Recalls Semaglutide Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Semaglutide 3 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0019-2027·2026-10-14
FDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling semaglutide/cyanocobalamin injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0017-2027·2026-10-14
FDA Recalls Tirzepatide Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tirzepatide 26 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0025-2027·2026-10-14
FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes because processing equipment used in compounding raised concerns about the product's sterility.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0007-2027·2026-10-14
K.C. Pharmaceuticals Recalls Good Sense Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling Good Sense Eye Drops Original Formula due to a lack of assurance of sterility. The recall affects 1,025,448 cartons distributed nationwide.
Product
GOODSENSE EYE DROPS ORIGINAL FORMULA — GOODSENSE EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0032-2027·2026-10-14
FDA Recalls Tri-MIX Syringes Due to Sterility Assurance Concerns
Carolina Infusion, LLC is recalling Tri-MIX compounded syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0004-2027·2026-10-14
K.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling Leader Advanced Relief Eye Drops and related brands due to a lack of assurance of sterility. The recall covers 208,896 cartons distributed nationwide.
Product
LEADER ADVANCED RELIEF EYE DROPS — LEADER ADVANCED RELIEF EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0037-2027·2026-10-14
Apothecary NAD+ Injection Recalled for Lack of Sterility Assurance
Apothecary Pharma is recalling NAD+ Injection vials due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0029-2027·2026-10-14
FDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 76/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0005-2027·2026-10-14
K.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
K.C. Pharmaceuticals is recalling multiple brands of eye drops due to a lack of assurance of sterility. The recall covers 1,435,830 cartons distributed nationwide.
Product
TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE — TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0023-2027·2026-10-14
FDA Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to processing equipment.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0031-2027·2026-10-14
Carolina Infusion Recalls Tri-MIX Injectable Due to Sterility Concerns
Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.
Product
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
Category
Drug
Distribution
Distributed nationwide

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1–25 of 18082