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

10001–10025 of 17987

ModerateFDA (Drugs)·D-0363-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Kits Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Daily Oral Cleansing Kits because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse. Contains: 10 Petite Size Oral Swabs, individually wrapped, 1.5 fl oz/44ml bottle of Antiseptic Oral Rinse, .5 oz/14g tube of Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0359-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination
Sage Products Inc. is recalling 835 cases of Toothette Oral Care Short Term Oral Swab Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette Plus Oral Swabs with sodium bicarbonate, 1.5 fl.oz/44ml bottle Perox-A-Mint solution, .5 oz/14g tube of Mouth Moisturizer, .3 oz./9g tube of Sodium Bicarbonate Mouthpaste, I Ultra-S
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0401-2018·2018-02-21
Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination Risk
Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-Mint s
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0402-2018·2018-02-21
Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination
Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0372-2018·2018-02-21
Sage Products Recalls Q Care Oral Care Kits Due to Cross-Contamination
Sage Products is recalling Q Care Continue Care kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6308 UPC 6 18029 83040 1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0403-2018·2018-02-21
Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination
Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated, CHG Compatible Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0396-2018·2018-02-21
Sage Products Recalls Q.CARE Oral Cleansing System Due to Cross-Contamination
Sage Products Inc is recalling Q.CARE Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Toothbrush packages with Antiplaque solution. 4 Suction Oral Swab packages with Perox-A-Mint solution. 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 39
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0387-2018·2018-02-21
Sage Products Recalls Oral Care Systems Due to Cross-Contamination
Sage Products Inc. is recalling Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate, Pe
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0370-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrushes
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes due to cross-contamination with non-pharmaceutical products during manufacturing.
Product
Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth Moisturizer, Contains 2 Suction Toothbrushes with sodium bicarbonate. 0.25 fl oz/7ml Antiseptic Oral Rinse, 0.07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Produ
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0384-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrush Due to Cross Contamination
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrush kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Contains 1 Suction Toothbrush with sodium Bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab, Sage Products, Inc., 3909 Three Oaks Road, Cary,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0374-2018·2018-02-21
Sage Q CARE Oral Cleansing System Recalled for Cross-Contamination
Sage Products is recalling Q CARE q2 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4 Oropharyngeal
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0391-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrush
Sage Products is recalling Toothette Oral Care Suction Toothbrush kits due to cross-contamination with non-pharmaceutical products during manufacturing.
Product
Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution. Contains 1 Suction Toothbrush with sodium bicarbonate, 0.25 fl oz/ 7ml Perox-A-Mint solution, 0.07 oz/2g Mouth Moisturizer, 1 Applicator Swab. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Cod
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0373-2018·2018-02-21
Sage Products Recalls Q CARE Oral Cleaning System Due to Cross-Contamination
Sage Products is recalling Q CARE q4 Oral Cleaning & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Q CARE q4 Oral Cleaning & Suctioning System Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6404 U
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0578-2018·2018-02-21
Teva Recalls Fluoxetine Tablets Due to Impurity Test Failures
Teva Pharmaceuticals USA is voluntarily recalling Fluoxetine Tablets USP, 10 mg, because routine stability testing revealed an out-of-specification lactoside impurity.
Product
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0357-2018·2018-02-21
Toothette Oral Rinse Recalled for Cross-Contamination Risk
Sage Products Inc. is recalling Toothette Oral Care Antiseptic Oral Rinse because it was manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Antiseptic Oral Rinse 1.5 fl.oz/44 ml. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6122 UPC 6 18029 80079 4
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0380-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Suction Swab System
Sage Products Inc. is recalling the Toothette Oral Care Suction Swab System because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction Swabs with sodium, bicarbonate and a .25 fl oz/7ml pouch of Perox-A-Mint solution, 10 Applicator Swabs, .5 oz/14g tube of Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks R
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0409-2018·2018-02-21
Sage Q Care RX Oral System Recalled for Cross-Contamination Risk
Sage Products is recalling Q Care RX Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 1 Single dose bottle of 0.12% CHG Oral Rinse, 2 Suction Oral Swab packages with Perox-A-Mint, 1
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0413-2018·2018-02-21
Allergan Recalls NORCO Tablets Due to Missing Controlled Substance Labeling
Allergan is recalling 8 bottles of NORCO tablets because the primary label is missing the required CII controlled drug classification indication.
Product
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0417-2018·2018-02-21
Sun Pharmaceutical Recalls Azelastine HCl Nasal Spray for Stability Test Failure
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution 0.1% because it failed a droplet size stability test. The recall covers 17,554 bottles distributed nationwide.
Product
AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0416-2018·2018-02-21
Genentech Recalls Klonopin Tablets Due to Missing Schedule IV Labeling
Genentech is recalling Klonopin (clonazepam) 0.5 mg tablets because the Schedule IV controlled substance indicator was omitted from the product carton.
Product
Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
Category
Drug
Distribution
0 states
CriticalFDA (Drugs)·D-0340-2018·2018-02-14
AuroMedics Recalls Pantoprazole Sodium Injection Due to Glass Particulate
AuroMedics Pharma LLC is recalling 66,100 vials of Pantoprazole Sodium for Injection because one vial contained a piece of glass.
Product
PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0339-2018·2018-02-14
Aurobindo Recalls Ampicillin and Sulbactam Injection Due to Glass Particulates
Aurobindo Pharma is recalling 53,040 vials of Ampicillin and Sulbactam for Injection due to a confirmed report of visible glass particulate matter.
Product
AMPICILLIN AND SULBACTAM — AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0337-2018·2018-02-14
AuroMedics Recalls Linezolid Injection Bags Due to Mold Contamination
AuroMedics Pharma LLC is recalling 9,050 bags of Linezolid Injection 600 mg/300 mL because white particulate matter identified as mold was found in one bag.
Product
LINEZOLID — LINEZOLID (LINEZOLID)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0333-2018·2018-02-14
Flawless Beauty LLC Recalls Ling Zhi Capsules for Misbranding
Flawless Beauty LLC is voluntarily recalling all lots of Ling Zhi capsules because they were marketed without an approved NDA/ANDA, constituting misbranding and unapproved new drugs.
Product
Ling Zhi capsules
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0332-2018·2018-02-14
Flawless Beauty Recalls Sterilized Water for Injections Due to Misbranding
Flawless Beauty LLC is voluntarily recalling all lots of sterilized water for injections sold in the U.S. because the products were marketed without FDA approval.
Product
Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
Category
Drug
Distribution
Distributed nationwide

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10001–10025 of 17987