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 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.

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8876–8900 of 18015

  • SevereFDA (Drugs)·D-0389-2019·2019-01-30

    Dr. Reddy's Recalls Ezetimibe and Simvastatin Tablets Due to Foreign Substance

    Dr. Reddy's is recalling specific bottles of Ezetimibe and Simvastatin tablets because black speckles were observed on the tablets.

    Product
    Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0390-2019·2019-01-30

    Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurities

    Lupin Pharmaceuticals is recalling 24,180 bottles of Fluocinolone Acetonide Topical Solution due to elevated impurities.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0430-2019·2019-01-30

    Heparin Injectable Solution Recalled for Incorrect Concentration Labeling

    Advanced Pharma Inc. is recalling Heparin Injectable Solution because the label incorrectly states the concentration as 50 mg/50 mL instead of 50 Units/50 mL.

    Product
    HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syringe, Avella of Houston an FDA Registered 503B Outsourcing Facility 9265 Kirby Dr. Houston, TX 77054 (877) 794-0404 ---- NDC: 42852-725-65
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-0391-2019·2019-01-30

    Sun Pharmaceutical Recalls Loperamide Hydrochloride Tablets Due to Labeling Error

    Sun Pharmaceutical Industries is recalling 5,040 cartons of Loperamide Hydrochloride 2 mg tablets because the carton front and side panels display conflicting caplet counts.

    Product
    LOPERAMIDE HYDROCHLORIDE — LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0367-2019·2019-01-23

    Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0368-2019·2019-01-23

    Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0369-2019·2019-01-23

    Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0364-2019·2019-01-23

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA testing found the impurity NDEA above acceptable daily intake levels.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0365-2019·2019-01-23

    Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA labs confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) above the interim acceptable daily intake level.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0363-2019·2019-01-23

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA labs found N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0361-2019·2019-01-23

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA is recalling Amlodipine and Valsartan tablets because FDA testing found NDEA impurity levels above the acceptable daily intake.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0366-2019·2019-01-23

    Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0370-2019·2019-01-23

    Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Valsartan tablets because FDA testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0362-2019·2019-01-23

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Amlodipine and Valsartan tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0378-2019·2019-01-23

    Syntho Recalls EEMT Tablets Due to Sub-Potency and cGMP Violations

    Syntho Pharmaceuticals is recalling 5,000 bottles of EEMT tablets because they were found to be sub-potent and involved cGMP violations.

    Product
    EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0381-2019·2019-01-23

    Teva Recalls Olmesartan Medoxomil and Hydrochlorothiazide Tablets for Dissolution Failure

    Teva Pharmaceuticals USA is recalling specific lots of Olmesartan Medoxomil and Hydrochlorothiazide Tablets because they failed to meet dissolution specifications.

    Product
    Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Phar
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0377-2019·2019-01-23

    Syntho Pharmaceuticals Recalls EEMT HS Tablets Due to Sub-Potency

    Syntho Pharmaceuticals is recalling 5,000 bottles of EEMT HS tablets due to sub-potency and cGMP violations. The product was distributed nationwide.

    Product
    EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0380-2019·2019-01-23

    Lupin Recalls Cephalexin Oral Suspension Due to Missing Manufacturing Records

    Lupin Pharmaceuticals is recalling 7,215 bottles of Cephalexin for Oral Suspension because the manufacturing batch record could not be located.

    Product
    Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0372-2019·2019-01-16

    Sun Pharmaceutical Recalls Vecuronium Bromide Due to Glass Particulates

    Sun Pharmaceutical Industries is recalling Vecuronium Bromide for Injection because glass particles were detected in the product.

    Product
    VECURONIUM BROMIDE — VECURONIUM BROMIDE (VECURONIUM BROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0358-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP due to the presence of grey rubber particulate matter in the vials.

    Product
    Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0351-2019·2019-01-16

    Baxter Recalls Dianeal Low Calcium Dialysis Solution Due to Sterility Concerns

    Baxter Healthcare is recalling 29,370 bags of Dianeal Low Calcium peritoneal dialysis solution because confirmed customer complaints identified leaks in the tubing, compromising sterility.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0355-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 250 mg, due to the presence of grey rubber particulate matter from stoppers in reconstituted vials.

    Product
    Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, due to the presence of grey rubber particulate matter from stoppers.

    Product
    Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0357-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP vials because grey rubber flecks were found in the reconstituted product.

    Product
    Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Li
    Category
    Drug
    Distribution
    Distributed nationwide