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

2076–2100 of 18005

ModerateFDA (Drugs)·D-0125-2024·2023-12-06
Compounded Ophthalmic Medication Bottles Mislabeled as Single-Use Syringes
Fagron Compounding Services is recalling 756 bottles of compounded ophthalmic medication because labels incorrectly identify the container as a 0.5mL single-use syringe instead of a 5mL dropper bottle. No adverse events have been reported.
Product
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, K
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0129-2024·2023-12-06
Paroxetine 20 mg Tablets Recalled for Out-of-Specification Impurity
Golden State Medical Supply is recalling certain lots of Paroxetine 20 mg tablets nationwide due to an out-of-specification chemical impurity in the product.
Product
PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0120-2024·2023-12-06
Paroxetine Tablets Recalled Due to Manufacturing Specification Failure
Apotex Corp. is recalling Paroxetine Hydrochloride 20 mg tablets nationwide due to out-of-specification impurity levels in affected lots. No illnesses have been reported.
Product
PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0127-2024·2023-12-06
Testosterone Gel Recalled for Out-of-Specification Viscosity
Teva Pharmaceuticals recalls specific lots of Testosterone Gel 1.62% for failing viscosity specifications. Patients should contact their healthcare provider to discuss the recall and obtain unaffected medication.
Product
TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0130-2024·2023-12-06
Paroxetine 40 mg tablets recalled for out-of-specification impurities
Golden State Medical Supply Inc. is recalling Paroxetine 40 mg tablets due to failed impurity specifications. A total of 5,626 bottles were distributed nationwide.
Product
PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0107-2024·2023-11-29
Polyvinyl Alcohol Eye Drops Recalled for Non-Sterile Manufacturing Conditions
FDA recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops nationwide due to non-sterile manufacturing conditions found during inspection.
Product
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0131-2024·2023-11-29
Eye Drops Recalled for Non-Sterility Issues from Manufacturing Facility
Cardinal Health is recalling LEADER brand Eye Irritation Relief drops due to non-sterility concerns. FDA testing found insanitary conditions and positive bacterial results at the manufacturing facility, affecting 11,629 units distributed nationwide.
Product
EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0132-2024·2023-11-29
FDA Recalls Non-Sterile Dry Eye Relief Drops Due to Bacterial Contamination
Cardinal Health is recalling all lots of LEADER brand Dry Eye Relief nationwide due to non-sterility. FDA found insanitary manufacturing conditions and positive bacterial test results.
Product
DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0118-2024·2023-11-29
ELCYS cysteine hydrochloride injection recalled for silicone contamination
Exela Pharma Sciences is recalling 38,200 vials of ELCYS (cysteine hydrochloride injection) nationwide due to the presence of silicone particulate matter.
Product
ELCYS — ELCYS (CYSTEINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0108-2024·2023-11-29
Lubricating Tears Eye Drops Recalled for Non-Sterility and Bacterial Contamination
Rugby Laboratories' Lubricating Tears Eye Drops are being recalled nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility.
Product
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0135-2024·2023-11-29
Eye drops recalled for non-sterility due to bacterial contamination
Cardinal Health's LEADER brand Dry Eye Relief eye drops are recalled nationwide due to non-sterility concerns. FDA found insanitary conditions and positive bacterial results from environmental sampling at the manufacturing facility.
Product
DRY EYE RELIEF — DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0134-2024·2023-11-29
FDA Recalls LEADER Brand Lubricant Eye Drops Due to Non-Sterility Risk
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results from the manufacturing facility.
Product
LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0136-2024·2023-11-29
LEADER Lubricant Eye Drops Recalled for Non-Sterility and Bacterial Contamination
Cardinal Health is recalling all lots of LEADER brand Lubricant Eye Drops due to non-sterility issues. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility in India.
Product
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0133-2024·2023-11-29
LEADER Lubricant Eye Drops Recalled Nationwide for Non-Sterility Concerns
LEADER brand Lubricant Eye Drops are being recalled nationwide due to non-sterility issues. FDA testing found insanitary conditions and positive bacterial contamination at the manufacturing facility.
Product
LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0117-2024·2023-11-29
Midazolam Injectable Recalled for Silicone Particulate Matter Contamination
Exela Pharma Sciences is recalling Midazolam Injectable due to silicone particulate matter contamination. Patients and healthcare providers with the affected lot should discontinue use and consult their healthcare provider.
Product
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial NDC 51754-2131-
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0116-2024·2023-11-29
FDA Recalls Sodium Bicarbonate Injection for Silicone Particulate Contamination
Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.
Product
SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0109-2024·2023-11-29
Hand Sanitizer Recalled for Acetal and Acetaldehyde Contamination
Integrity Biochem HSC 70-LM hand sanitizer in 55-gallon drums (Lot #2133607, manufactured 11/23/2021) is being recalled due to acetal and acetaldehyde contamination above FDA standards. Product was distributed to an Oklahoma distributor.
Product
Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0113-2024·2023-11-29
Buspirone Hydrochloride Tablets Recalled Due To Amlodipine Contamination Risk
FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0111-2024·2023-11-29
Hand Sanitizer Recalled for Excess Acetal and Acetaldehyde Contamination
Integrity Biochem hand sanitizer recalled due to contamination with acetal and acetaldehyde at levels above FDA standards. The product was distributed to one Oklahoma distributor.
Product
Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0110-2024·2023-11-29
Hand Sanitizer Recalled for Chemical Contamination Above Specifications
Integrity Biochem 70% alcohol hand sanitizer recalled due to acetal and acetaldehyde contamination above USP limits. The 55-gallon drums distributed in Oklahoma may not meet safety standards.
Product
Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0115-2024·2023-11-29
Tiglutik riluzole oral suspension recalled for failed viscosity specifications
ITF Pharma is recalling 1,792 bottles of Tiglutik (riluzole) oral suspension due to out-of-specification viscosity test results. The affected lots are 2231901 and 2307901, distributed to Tennessee.
Product
TIGLUTIK — TIGLUTIK (RILUZOLE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0112-2024·2023-11-29
Prescription esomeprazole magnesium capsules recalled for failed impurity specifications
Glenmark Pharmaceuticals recalled esomeprazole magnesium 20mg capsules nationwide due to out-of-specification organic impurities detected during stability testing. No illnesses have been reported.
Product
ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0114-2024·2023-11-29
Lisinopril Tablets Recalled for Stray Amlodipine Tablet Contamination
NCS Healthcare recalled Lisinopril Tablets USP 20 mg nationwide due to potential presence of stray Amlodipine Besylate 10 mg tablets in certain lots. No illnesses have been reported.
Product
BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0106-2024·2023-11-22
Compressed Oxygen Cylinders Recalled Due to Manufacturing Quality Deviations
Family Medical Supply Inc is recalling 26,657 cylinders of compressed oxygen distributed nationwide due to manufacturing practice deviations. Cylinders were manufactured between May 10 and October 31, 2023.
Product
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0104-2024·2023-11-22
DOP Instant Hand Sanitizer Recalled for Potency Defects in Puerto Rico
Omega & Delta Co. is recalling DOP Instant Hand Sanitizer because certain lot numbers did not meet potency acceptance criteria. Affected products were distributed in Puerto Rico only.
Product
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4
Category
Drug
Distribution
1 state

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2076–2100 of 18005