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

6351–6375 of 11823

SevereFDA (Drugs)·D-0378-2018·2018-02-21
Sage Products Recalls Oral Cleaning Systems Due to Cross-Contamination
Sage Products Inc. is recalling 852 cases of Oral Cleaning and Suctioning System q2 because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint- solution, 6 Suction Oral Swab packages with Alcohol-Free Mouthwash solution, 2 Oropharyngeal Suct
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0406-2018·2018-02-21
Sage Q Care RX Oral System Recalled for Cross Contamination
Sage Products is recalling Q Care RX Oral Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab package
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0347-2018·2018-02-21
FDA Recalls Unapproved Limbrel500 Capsules Marketed Without Approval
Primus Pharmaceuticals is recalling Limbrel500 capsules because they were marketed without FDA approval, meaning their safety and efficacy have not been established.
Product
Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-606-16.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0408-2018·2018-02-21
Sage Products Recalls Oral Care System Due to Cross Contamination
Sage Products Inc. is recalling the Q Care Oral Cleansing & Suctioning System because it was manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Ri
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0385-2018·2018-02-21
Sage Products Recalls Oral Cleansing Systems Due to Cross-Contamination
Sage Products Inc is recalling Oral Cleansing & Suctioning Systems with 0.12% Chlorexidine Gluconate Oral Rinse because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, packages SYS W/CHG 10, Sage Products, Inc., 3909 Three
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0398-2018·2018-02-21
Sage Q.Care Oral Cleansing System Recalled for 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 with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Suction Handle, 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 wit
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0365-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer. Contains 2 Toothette Plus Swabs with sodium bicarbonate, .25 fl oz/7ml Perox-A-Mint solution and .07 oz/2g Mouth Moisturizer, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Produc
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0407-2018·2018-02-21
Sage Products Recalls Q Care RX Oral System Due to Cross Contamination
Sage Products is recalling 25 cases of Q Care RX Petite Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab package
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0394-2018·2018-02-21
Sage Q.Care Oral System Recalled for Cross-Contamination Risk
Sage Products is recalling Q.Care Oral Cleansing Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.
Product
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and Y-Connector, 2 Petit Size Suction Toothbrushes, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturizer, 4 Petit Size Untreated Suction Oral Swabs, 7ml Antiseptic Oral Rinse, Appli
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0353-2018·2018-02-21
Sage Products Recalls Toothette Suction Toothbrush Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Suction Toothbrush kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer. Includes 0.25 fl.oz./7mL Perox-A-Mint solution, 0.07oz/2g Mouth Moisturizer. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. NDC: 53462-922-16
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0423-2018·2018-02-21
PharMEDium Recalls Ropivacaine Cassettes Due to Sterility Assurance Failure
PharMEDium Services, LLC is recalling 21 cassettes of 0.2% Ropivacaine HCI due to a failure to follow proper testing procedures, raising concerns about sterility and endotoxin levels.
Product
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-0381-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Suction Swab System
Sage Products Inc. is recalling Toothette Oral Care Suction Swab Systems due to cross-contamination with non-pharmaceutical products during manufacturing.
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, 2 Packages of 1 Suction Toothbrush with sodium bicarbonate and a .25 fl oz/7ml pouch of Perox-A-
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0383-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Suction Toothbrushes Due to Cross-Contamination
Sage Products Inc. is recalling Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction toothbrush with sodium bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6571
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0346-2018·2018-02-21
Primus Pharmaceuticals Recalls Unapproved Limbrel250 Capsules Nationwide
Primus Pharmaceuticals is recalling 4,006 bottles of Limbrel250 capsules because the product was marketed without an approved NDA or ANDA, meaning its safety and efficacy have not been established.
Product
Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-605-16.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0424-2018·2018-02-21
PharMEDium Recalls Phenylephrine Injection Due to Sterility Assurance Failure
PharMEDium Services, LLC is recalling 500 syringes of Phenylephrine HCl Injection due to a lack of assurance of sterility and potential endotoxin issues.
Product
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-0345-2018·2018-02-21
Primus Pharmaceuticals Recalls Unapproved Limbrel Flavocoxid Capsules Nationwide
Primus Pharmaceuticals is recalling Limbrel (flavocoxid 500 mg) capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-602-16.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0364-2018·2018-02-21
Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination
Sage Products is recalling Toothette Oral Care Single Use Systems because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs with sodium bicarbonate, .25 fl oz/7ml tube of Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6012 UPC (01)00618029800077
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0422-2018·2018-02-21
PharMEDium Recalls Oxytocin Injection Bags Due to Sterility Concerns
PharMEDium Services, LLC is recalling 24 bags of Oxytocin Injection due to a lack of assurance of sterility and potential endotoxin issues.
Product
15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-0362-2018·2018-02-21
Sage Products Recalls Corinz Oral Care Kits Due to Cross-Contamination
Sage Products is recalling 94 cases of Independent Care System Corinz oral care kits because they were manufactured on equipment shared with non-pharmaceutical products.
Product
Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g tube of Mouth Moisturizer, 0.3 oz/9g tube of Sodium Bicarbonate Mouthpast, 1 Ultra-Soft toothbrush. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6004 UPC 6 18029 821
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0356-2018·2018-02-21
Sage Products Recalls Oral Cleansing Systems Due to Cross-Contamination Risk
Sage Products Inc. is recalling 2,199 cases of Oral Cleansing & Suctioning System q4 because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.
Product
Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Car
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0405-2018·2018-02-21
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 Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab pack
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-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-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-0326-2018·2018-02-14
Flawless Beauty Recalls Tatiomax Glutathione Whitening Kits Nationwide
Flawless Beauty LLC is voluntarily recalling Tatiomax Glutathione Whitening kits nationwide because the products were marketed without FDA approval.
Product
Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan
Category
Drug
Distribution
Distributed nationwide

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6351–6375 of 11823