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

6376–6400 of 11823

SevereFDA (Drugs)·D-0334-2018·2018-02-14
Flawless Beauty Recalls Unapproved Saluta Glutathione Whitening Kits Nationwide
Flawless Beauty LLC is voluntarily recalling all lots of Saluta Glutathione Whitening kits nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Product
Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC
Category
Drug
Distribution
Distributed nationwide
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
SevereFDA (Drugs)·D-0331-2018·2018-02-14
Flawless Beauty Recalls Vitamin C Ampules for Misbranding and Unapproved Status
Flawless Beauty LLC is voluntarily recalling all lots of TP Drug Laboratories Vitamin C ampules nationwide because they were marketed without an approved NDA/ANDA.
Product
TP Drug Laboratories Vitamin C ampules
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0322-2018·2018-02-14
FDA Recalls Sterile Morphine Sulfate Preparations Due to Sterility Concerns
Intrathecal Compounding Specialist, LLC is recalling sterile morphine sulfate preparations compounded between October 16 and November 17, 2017, due to a lack of sterility assurance.
Product
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
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
SevereFDA (Drugs)·D-0321-2018·2018-02-14
FDA Recalls Hydromorphone Sterile Drug Preparations for Lack of Sterility Assurance
Intrathecal Compounding Specialist is recalling sterile drug preparations made from Hydromorphone Base Solution due to a lack of sterility assurance.
Product
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0320-2018·2018-02-14
FDA Recalls Fentanyl Citrate Sterile Drug Preparations for Sterility Concerns
Intrathecal Compounding Specialist, LLC is recalling sterile drug preparations made from Fentanyl Citrate Base Solution due to a lack of sterility assurance.
Product
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0323-2018·2018-02-14
FDA Recalls Sufentanil Citrate Preparations Due to Sterility Concerns
The FDA is recalling sterile drug preparations made from Sufentanil Citrate Base Solution due to a lack of sterility assurance. The products were compounded by Intrathecal Compounding Specialists.
Product
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0330-2018·2018-02-14
Flawless Beauty Recalls Reiki Glutathione Whitening Kits for Misbranding
Flawless Beauty LLC is voluntarily recalling all lots of Reiki Glutathione Whitening kits because they were marketed without an approved NDA or ANDA.
Product
Reiki Glutathione Whitening kits
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0328-2018·2018-02-14
Flawless Beauty Recalls Unapproved Glutathione Injectable Products Nationwide
Flawless Beauty LLC is voluntarily recalling all lots of Tationil Glutathione and other products sold in kits. The recall is due to misbranding and the sale of unapproved new drugs under a court order.
Product
Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.
Category
Drug
Distribution
Distributed nationwide
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
HighFDA (Drugs)·D-0324-2018·2018-02-14
Flawless Beauty Recalls Relumins Advanced Glutathione Kits Nationwide
Flawless Beauty LLC is voluntarily recalling all lots of Relumins Advanced Glutathione kits nationwide because the products were marketed without FDA approval.
Product
Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0329-2018·2018-02-14
Flawless Beauty Recalls Unapproved Laennec Placenta Extract Injections
Flawless Beauty LLC is voluntarily recalling Laennec INJ placenta extract vials because they were marketed without FDA approval.
Product
Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0472-2018·2018-02-07
Clopidogrel Tablets Recalled Due to Simvastatin Labeling Error
International Laboratories, LLC is recalling Clopidogrel Tablets 75 mg because bottles were found containing Simvastatin Tablets 10 mg.
Product
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0563-2018·2018-02-07
FDA Recalls Unapproved Zhonghua Niubian Tablets Containing Sildenafil
A&H Focal Inc. is recalling Zhonghua Niubian tablets found to contain sildenafil, an unapproved drug for erectile dysfunction.
Product
Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Category
Drug
Distribution
2 states
CriticalFDA (Drugs)·D-0558-2018·2018-02-07
FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets
A&H Focal Inc. is recalling LANG YI HAO CHAONONGSUOPIAN tablets because they contain sildenafil without FDA approval. The products were sold in New York and New Jersey.
Product
LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
Category
Drug
Distribution
2 states
CriticalFDA (Drugs)·D-0247-2018·2018-02-07
Blue Pearl Capsules Recalled for Undeclared Sildenafil
Blue Fusion Natural is recalling Blue Pearl capsules because FDA analysis found undeclared sildenafil, an unapproved drug for erectile dysfunction.
Product
BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0263-2018·2018-02-07
Medline Catheter Care Tray Recalled for Subpotent Iodine Concentration
Medline Industries is recalling lidded catheter care trays because the povidone-iodine prep pads contain less iodine than the label claims.
Product
Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0277-2018·2018-02-07
Medline Recalls Sterile Povidone-Iodine Prep Pads Due to Low Iodine Content
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled claim of 0.85%.
Product
Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0562-2018·2018-02-07
Unapproved Sildenafil Tablets Recalled by FDA for Lack of Safety Data
The FDA is recalling ZHANSHENG WEIGE CHAOYUE XILISHI tablets because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
Product
ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0573-2018·2018-02-07
Baxter Recalls Nexterone Injection Due to Polyethylene Particulate Matter
Baxter Healthcare is recalling Nexterone (amiodarone HCl) Premixed Injection because polyethylene particulate matter was identified in the product packaging.
Product
NEXTERONE — NEXTERONE (AMIODARONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0282-2018·2018-02-07
Medline Recalls Subpotent Povidone-Iodine Prep Pads
Medline Industries is recalling sterile staple remover trays containing subpotent povidone-iodine prep pads. The iodine concentration is below the labeled claim of 0.85%.
Product
Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60060
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0262-2018·2018-02-07
Medline Trunk Kit Recalled for Subpotent Povidone-Iodine Concentration
Medline Industries is recalling 231 cases of Trunk Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
Product
Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0560-2018·2018-02-07
FDA Recalls Unapproved Clalis Capsules Containing Sildenafil
A&H Focal Inc. is recalling Clalis capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
Product
Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0568-2018·2018-02-07
FDA Recalls Unapproved Power V8 Viagra Tablets Containing Sildenafil
A&H Focal Inc. is recalling Power V8 Viagra tablets because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
Product
Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
Category
Drug
Distribution
2 states

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6376–6400 of 11823