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

2276–2300 of 5047

HighFDA (Drugs)·D-0929-2023·2023-07-26
Vancomycin IV Bags Recalled Due to Manufacturing Environment Contamination Risk
New England Life Care is recalling Vancomycin HCl IV bags due to potential CGMP violations that may have compromised the production environment. The recall affects 209 bags distributed nationwide.
Product
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0930-2023·2023-07-26
Sodium Bicarbonate Injectable Solution Recalled for Sterility Assurance Issues
SterRx is recalling 137,304 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide because the manufacturer cannot assure the product meets sterility standards. Affected lots have expiration dates from July 2023 through February 2024.
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0931-2023·2023-07-26
Norepinephrine injectable recalled due to sterility assurance concerns
SterRx is recalling norepinephrine injections due to lack of assurance of sterility. The recall affects 132,299 bags distributed nationwide.
Product
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0926-2023·2023-07-26
Succinylcholine Chloride Injectable Drug Recalled Nationwide for Manufacturing Facility Contamination Risk
Advanced Compounding Solutions is recalling 493 syringes of succinylcholine chloride injection due to potential contamination from manufacturing facility violations affecting product sterility.
Product
SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0923-2023·2023-07-26
Tizanidine Tablets Recalled Nationwide for Failed Dissolution Specification
Dr. Reddy's Laboratories is recalling Tizanidine 4 mg tablets nationwide because 24-month stability testing revealed dissolution specification failures. No illnesses or injuries have been reported.
Product
TIZANIDINE — TIZANIDINE (TIZANIDINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0928-2023·2023-07-26
Rocuronium Bromide Injectable Recalled Due to CGMP Violations
Advanced Compounding Solutions is recalling Rocuronium Bromide 10 mg/mL injectables (lot #20230524-530F73) nationwide due to CGMP violations. Production spaces adjacent to the manufacturing area may have been compromised.
Product
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0925-2023·2023-07-26
Prescription drug recall: Fingolimod capsules fail dissolution specifications
Ascend Laboratories is recalling 2,652 bottles of Fingolimod capsules nationwide because they failed to meet dissolution specifications, potentially affecting medication effectiveness.
Product
FINGOLIMOD — FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0927-2023·2023-07-26
FDA Recalls Phenylephrine HCl IV Solution Over Manufacturing Contamination
Advanced Compounding Solutions is recalling 82 bags of phenylephrine HCl intravenous solution due to potential contamination from manufacturing facility violations. No illnesses have been reported.
Product
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0924-2023·2023-07-26
Loteprednol Etabonate Eye Drops Recalled for Out-of-Specification Potency
Sun Pharmaceutical recalls Loteprednol Etabonate eye drops due to out-of-specification unit dose content in certain lots. Affected bottles may contain incorrect potency levels.
Product
LOTEPREDNOL ETABONATE — LOTEPREDNOL ETABONATE (LOTEPREDNOL ETABONATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0939-2023·2023-07-26
Famotidine tablets recalled for carton labeling error on strength
Glenmark Therapeutics is recalling famotidine 20 mg tablets after some cartons were labeled with a side label indicating 10 mg instead. The medication inside is correct; only the external carton label is mislabeled.
Product
FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0938-2023·2023-07-19
Prescription albuterol inhalers recalled nationwide due to defective valve seals
Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.
Product
ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0921-2023·2023-07-19
Artificial Tears Eye Drops Recalled for Bacterial Contamination
Delsam Pharma's Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. Consumers should stop using affected products immediately.
Product
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0919-2023·2023-07-19
EzriCare Artificial Tears Eye Drops Recalled for Bacterial Contamination
EzriCare Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. The FDA identified non-sterile products that could pose a risk to eye health.
Product
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0918-2023·2023-07-19
FDA Recalls Bivalirudin Injectable Drug Due to Particulate Matter
Accord Healthcare is recalling Bivalirudin for Injection lot M2212070 due to the presence of fiber particles. Bivalirudin is an injectable blood thinner used in cardiac procedures.
Product
BIVALIRUDIN — BIVALIRUDIN (BIVALIRUDIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0922-2023·2023-07-19
Artificial Tears Eye Drops Recalled Due to Manufacturing Facility Contamination
Delsam Pharma's artificial tears eye drops are being recalled nationwide due to confirmed contamination linked to manufacturing facility defects. All affected lots were distributed via two distributors.
Product
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0920-2023·2023-07-19
EzriCare Artificial Tears Eye Drops Recalled for Manufacturing Contamination
EzriCare Artificial Tears eye drops are being recalled nationwide due to manufacturing facility contamination and CGMP deviations. The recall includes multiple lot numbers distributed nationwide.
Product
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0914-2023·2023-07-19
FDA Recalls Tiagabine Hydrochloride Tablets Due to Impurity Specification Failures
Sun Pharmaceutical is recalling Tiagabine Hydrochloride Tablets (2 mg) due to out-of-specification impurities detected during testing. The recall affects lot HAC3339A distributed nationwide.
Product
TIAGABINE HYDROCHLORIDE — TIAGABINE HYDROCHLORIDE (TIAGABINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0903-2023·2023-07-19
Allergy Relief Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications
CVS Pharmacy is recalling 16,200 cartons of Allergy Relief fexofenadine hydrochloride tablets nationwide due to failed impurities and degradation specifications. Stop using affected lot 2DV1925 and consult a pharmacist.
Product
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 69842-0914-39
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0908-2023·2023-07-19
Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications
L. Perrigo is recalling 32,376 cartons of Good Sense Aller Ease antihistamine tablets nationwide due to failed quality specifications affecting impurities and degradation. Consult your healthcare provider if you have taken this product.
Product
GOOD SENSE ALLER EASE — GOOD SENSE ALLER EASE (FEXOFENADINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0916-2023·2023-07-19
Sodium Chloride Injection Bags Recalled for Potential Leakage and Sterility Risk
B. Braun Medical Inc. is recalling 79,880 bags of Sodium Chloride Injection due to potential leakage that could compromise sterility. No illnesses or injuries have been reported.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0902-2023·2023-07-19
Careone Allergy Relief tablets recalled for failed impurity and degradation specifications
Careone Allergy Relief fexofenadine hydrochloride 180mg tablets are recalled nationwide for failing impurity and degradation specifications. Lot 2JE2185 with expiration date 01/24 is affected.
Product
CAREONE ALLERGY RELIEF — CAREONE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0909-2023·2023-07-19
Allergy Relief Fexofenadine Tablets Recalled for Failed Impurity Specifications
L. Perrigo's Allergy Relief 180 mg tablets are being recalled due to failed impurity and degradation specifications. The recall affects 32,904 cartons distributed nationwide.
Product
ALLERGY RELIEF — ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0907-2023·2023-07-19
Fexofenadine Hydrochloride Tablets Recalled for Failed Purity Specifications
L. Perrigo Company is recalling 15,504 cartons of Fexofenadine Hydrochloride 180 mg tablets nationwide due to failed impurity and degradation specifications.
Product
FEXOFENADINE HYDROCHLORIDE — FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0897-2023·2023-07-19
Sunmark and Generic Eye Drops Recalled for Manufacturing Deficiency
K.C. Pharmaceuticals is recalling 341,568 bottles of Sunmark and generic tetrahydrozoline eye drops due to manufacturing practice deficiencies. The recall affects multiple brands distributed nationwide.
Product
SUNMARK EYE DROPS ORIGINAL FORMULA — SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0901-2023·2023-07-19
Berkley Jensen Allergy Relief Recalled for Failed Quality Specifications
L. Perrigo Company is recalling Berkley Jensen Allergy Relief tablets due to failed product quality specifications involving impurities and degradation. Consumers should verify their lot numbers and expiration dates.
Product
BERKLEY JENSEN ALLERGY RELIEF — BERKLEY JENSEN ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide

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2276–2300 of 5047