The Recall Desk

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 the agency’s own highest classification or reported deaths or serious injuries, 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.

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11251–11275 of 17785

  • ModerateFDA (Drugs)·D-0168-2017·2016-12-07

    Nationwide Laboratories Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations

    Nationwide Laboratories LLC is recalling Phenazopyridine Hydrochloride Tablets, 200 mg, due to manufacturing deviations that may result in assay or content uniformity failures.

    Product
    Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0161-2017·2016-12-07

    Burel Pharmaceuticals Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations

    Burel Pharmaceuticals is recalling 17,788 bottles of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0160-2017·2016-12-07

    Burel Pharmaceuticals Recalls Indiomin MB Capsules Due to Manufacturing Deficiencies

    Burel Pharmaceuticals is recalling 795 bottles of Indiomin MB capsules due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0153-2017·2016-11-30

    Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips

    Hospira is recalling specific lots of Fentanyl Citrate Injection ampules because broken tips may compromise sterility.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0146-2017·2016-11-30

    VistaPharm Recalls Lactulose Solution Due to Bacterial Contamination

    VistaPharm is recalling Lactulose Solution, USP, 10 g/15 mL, because bulk solution tested positive for Burkholderia cepacia bacteria.

    Product
    Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0152-2017·2016-11-30

    Akorn Recalls Desoximetasone Ointment for Stability Failures

    Akorn Inc. is recalling Desoximetasone Ointment USP, 0.25%, due to failed stability specifications and phase separation.

    Product
    Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1045-2017·2016-11-30

    West-Ward Recalls Phenobarbital Tablets Due to Dissolution Failure

    West-Ward Pharmaceuticals is recalling specific lots of Phenobarbital Tablets because they failed to meet dissolution specifications at the 12-month stability time point.

    Product
    PHENOBARBITAL — PHENOBARBITAL (PHENOBARBITAL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0143-2017·2016-11-30

    Actavis Recalls Nifedipine Capsules Due to Presence of Foreign Tablets

    Actavis Elizabeth LLC is recalling Nifedipine Capsules USP, 10 mg, because the product may contain foreign tablets or capsules.

    Product
    NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0144-2017·2016-11-30

    AHP Nifedipine Capsules Recalled for Presence of Foreign Tablets

    Amerisource Health Services is recalling AHP Nifedipine Capsules, 10mg, due to the presence of foreign tablets or capsules in the packaging.

    Product
    AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0148-2017·2016-11-30

    Sun Pharmaceutical Recalls KENALOG Spray Due to Low Alcohol Content

    Sun Pharmaceutical Industries is recalling KENALOG (Triamcinolone Acetonide) Spray due to low alcohol content. The product failed stability specifications.

    Product
    KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0151-2017·2016-11-30

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules because of out-of-specification results for a known compound.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0145-2017·2016-11-30

    Sandoz Recalls Ceftriaxone Sodium Vials Due to Missing Labels

    Sandoz Inc is recalling 139,430 vials of Ceftriaxone Sodium for Injection in Wisconsin due to missing labels.

    Product
    CEFTRIAXONE SODIUM — CEFTRIAXONE SODIUM (CEFTRIAXONE SODIUM)
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0147-2017·2016-11-30

    West-Ward Recalls Amoxicillin Suspension Due to Missing Strength Label Panel

    West-Ward Pharmaceuticals is recalling 32,102 bottles of Amoxicillin oral suspension because some bottles are missing the color-coded panel that displays the product strength.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2017·2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection vials because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0140-2017·2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0137-2017·2016-11-23

    Amerisource Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failure

    Amerisource Health Services is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because stability samples failed dissolution specifications.

    Product
    Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0139-2017·2016-11-23

    CutisPharma Recalls Omeprazole Compounding Kits Due to Labeling Error

    CutisPharma is recalling 5,904 kits of FIRST Omeprazole 2mg/mL because the package insert incorrectly lists the strength as 3mg/mL.

    Product
    FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0142-2017·2016-11-23

    GSK Recalls Zeasorb AF Antifungal Cream Due to Labeling Errors

    GSK Consumer Healthcare is recalling Zeasorb AF antifungal cream because some bottles have incorrect NDC codes or indications on the labels.

    Product
    Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0138-2017·2016-11-23

    CutisPharma Recalls Omeprazole Kits Due to Labeling Error

    CutisPharma is recalling 8,748 Omeprazole compounding kits because the package insert incorrectly lists the strength as 3mg/mL instead of 2mg/mL.

    Product
    FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2017·2016-11-16

    Sandoz Recalls Transderm Scop Patches Due to Defective Delivery System

    Sandoz Inc is recalling 42,740 cartons of Transderm Scop (scopolamine) transdermal systems in Tennessee due to a defective delivery system that may alter drug release.

    Product
    Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0126-2017·2016-11-16

    FDA Recalls Wells Pharmacy Testosterone and Anastrozole Pellets

    Wells Pharmacy Network is recalling compounded Testosterone 200 mg/Anastrozole 9 mg Pellets because they are superpotent or subpotent.

    Product
    Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
    Category
    Drug
    Distribution
    0 states