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

3476–3500 of 8589

CriticalFDA (Drugs)·D-0839-2018·2018-05-23
Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials
Apotex Inc. is recalling 121,693 vials of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.
Product
Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0926-2018·2018-05-23
AuroMedics Recalls Piperacillin and Tazobactam Injection Due to Glass Particulates
AuroMedics Pharma LLC is recalling 77,400 vials of Piperacillin and Tazobactam for Injection due to confirmed visible glass particulate matter.
Product
PIPERACILLIN AND TAZOBACTAM — PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0840-2018·2018-05-23
Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials
Apotex Inc. is recalling specific lots of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.
Product
Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0811-2018·2018-05-23
Milbar Recalls B Prox 10 Anti-blemish Wash Due to Microbial Contamination
Milbar Laboratories is recalling 3,477 bottles of B Prox 10 Anti-blemish Wash due to microbial contamination. Consumers should stop using the product and return it to the point of purchase.
Product
B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0780-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Temozolomide 20 mg Due to Processing Controls
Kroger Specialty Pharmacy is recalling Temozolomide 20 mg capsules because of a lack of processing controls. The affected products were dispensed in five states.
Product
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-0728-2018·2018-05-16
Vitalab Methylcobalamin Injection Recalled Due to Sterility Concerns
Vitalab Pharmacy is recalling 178 vials of Methylcobalamin for injection because airflow patterns may not support aseptic production, raising sterility concerns.
Product
Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0795-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Perjeta Vials Due to Processing Controls
Kroger Specialty Pharmacy is recalling Perjeta 420 mg/14 mL vials due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Product
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-0792-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Bendeka Due to Lack of Processing Controls
Kroger Specialty Pharmacy is recalling Bendeka 25 mg/mL 4 mL MDVPF due to a lack of processing controls. The affected product was dispensed in five states between December 2017 and February 2018.
Product
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-0769-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Xtandi Capsules Due to Processing Controls
Kroger Specialty Pharmacy is recalling Xtandi 40 mg capsules due to a lack of processing controls. The affected products were dispensed in five states.
Product
Xtandi 40 mg capsule NDC 00469-0125-99 30 days supply
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-0866-2018·2018-05-16
AuroMedics Recalls Ampicillin and Sulbactam Injection Due to Particulate Matter
AuroMedics Pharma LLC is recalling 54,720 vials of Ampicillin and Sulbactam for Injection due to confirmed reports of visible red rubber particles.
Product
AMPICILLIN AND SULBACTAM — AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0731-2018·2018-05-16
Vitalab Pharmacy Recalls Sterile Injectable Due to Sterility Concerns
Vitalab Pharmacy, Inc. is recalling a sterile injectable drug product because airflow patterns may not support aseptic production, raising sterility concerns.
Product
Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0735-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Albuterol Inhalation Solution Due to Processing Controls
Kroger Specialty Pharmacy is recalling Albuterol 0.083% Inhalation Solution due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Product
Albuterol 0.083% Inh Sol. 30 days supply, Rx Only, 39183, NDC 76204-0200-60, 30
Category
Drug
Distribution
5 states
SevereFDA (Food)·F-1401-2018·2018-05-16
FDA Recalls Energique Herbal Supplements for Unapproved Drug Claims
Grato Holdings is recalling Energique herbal supplements because they are marketed as unapproved new drugs based on disease claims.
Product
Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0791-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Capecitabine Tablets Due to Processing Controls
Kroger Specialty Pharmacy is recalling Capecitabine 500 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Product
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-0778-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Glatiramer Acetate Due to Processing Controls
Kroger Specialty Pharmacy is recalling Glatiramer Acetate 40 mg/mL due to a lack of processing controls. The affected product was dispensed in five states.
Product
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Category
Drug
Distribution
5 states
SevereFDA (Food)·F-1400-2018·2018-05-16
Peaceful Mountain Stomach Rescue Recalled as Unapproved New Drug
Grato Holdings is recalling Peaceful Mountain Stomach Rescue dietary supplements because they are unapproved new drugs based on disease claims.
Product
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0730-2018·2018-05-16
Vitalab Pharmacy Recalls Sterile Injectable Drug Due to Sterility Concerns
Vitalab Pharmacy is recalling 22 vials of a sterile injectable drug because airflow patterns may not support aseptic production, raising sterility concerns.
Product
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0732-2018·2018-05-16
Vitalab Pharmacy Recalls Sterile Injectable Drugs Due to Sterility Concerns
Vitalab Pharmacy is recalling specific lots of sterile injectable drugs because airflow patterns may not support aseptic production, raising sterility concerns.
Product
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0768-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Pomalyst Capsules Due to Processing Controls
Kroger Specialty Pharmacy is recalling Pomalyst 3 mg capsules dispensed in five states due to a lack of processing controls.
Product
Pomalyst 3 mg capsule NDC 59572-0503-21 28 days supply
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-0754-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Azithromycin Tablets Due to Processing Controls
Kroger Specialty Pharmacy is recalling Azithromycin 250 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Product
Azithromycin 250 mg tablet #18 TEV NDC 50111-0787-66 28 days supply
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-0729-2018·2018-05-16
Vitalab Alprostadil Injectable Recalled for Sterility Assurance Concerns
Vitalab Pharmacy is recalling Alprostadil 20 mcg/mL injectable vials because airflow patterns may not support aseptic production, raising sterility concerns.
Product
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0797-2018·2018-05-16
Kroger Specialty Pharmacy Recalls Tasigna Capsules Due to Processing Controls
Kroger Specialty Pharmacy is recalling Tasigna Capsules 150 mg due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.
Product
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-0706-2018·2018-05-09
AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns
AuroMedics Pharma LLC is recalling Levetiracetam Injection due to a lack of assurance of sterility and a confirmed report of leaking bags and mold.
Product
LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0804-2018·2018-05-09
Sanofi Recalls Over-Concentrated Docetaxel Injection Vials Nationwide
Sanofi-Aventis is recalling 19,580 vials of Docetaxel injection concentrate due to potential over-concentration. The affected lots were distributed nationwide.
Product
DOCETAXEL — DOCETAXEL (DOCETAXEL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0704-2018·2018-05-09
AuroMedics Recalls Levofloxacin IV Bags Due to Sterility Concerns
AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.
Product
LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
Category
Drug
Distribution
Distributed nationwide

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