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.

Filters

Agency

Category

Minimum severity

Clear filters

8701–8725 of 17772

  • SevereFDA (Drugs)·D-0409-2019·2019-02-06

    Prinston Recalls Irbesartan Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan 300 mg tablets because FDA testing found N-nitrosodimethylamine (NDEA) levels above the interim acceptable daily intake.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0423-2019·2019-02-06

    Lupin Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 14,400 bottles of Cephalexin for Oral Suspension due to CGMP deviations and the presence of extraneous material in sucrose excipients.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0412-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable limits.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0413-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc is recalling Irbesartan and Hydrochlorothiazide tablets because FDA labs found the impurity NDEA above acceptable levels.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0410-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0422-2019·2019-02-06

    BromSite Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Sun Pharmaceutical is recalling BromSite (bromfenac) 0.075% ophthalmic solution due to a lack of sterility assurance. The recall affects 69,840 bottles distributed nationwide.

    Product
    BROMSITE — BROMSITE (BROMFENAC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0421-2019·2019-02-06

    Domperidone 10 mg Capsules Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling 840 capsules of Domperidone 10 mg due to a lack of processing controls. The product was distributed in Tennessee.

    Product
    Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0420-2019·2019-02-06

    Progesterone 100 mg SR Capsules Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling 1,306 capsules of Progesterone 100 mg SR due to a lack of processing controls.

    Product
    Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0428-2019·2019-02-06

    Mylan Recalls Fexofenadine Tablets Due to Elevated Impurities

    Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 180 mg tablets because routine stability testing showed slightly elevated related compounds.

    Product
    Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0415-2019·2019-02-06

    Gentamicin Ophthalmic Solution Recalled for Crystalline Particulate Matter

    H J Harkins Company is recalling Gentamicin Ophthalmic Solution due to crystalline particles found during clarity testing.

    Product
    GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0418-2019·2019-02-06

    Testosterone Cream Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling Testosterone 0.1% cream due to a lack of processing controls. The product was distributed in Tennessee.

    Product
    Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0414-2019·2019-02-06

    Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Particulate Matter

    Akorn, Inc. is recalling specific lots of Gentamicin Sulfate Ophthalmic Solution because crystalline particles were detected during clarity testing.

    Product
    Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0416-2019·2019-02-06

    Duren Health Mart Pharmacy Recalls Omeprazole Suspension Due to Processing Controls

    Duren Health Mart Pharmacy is recalling Omeprazole 4 mg/mL Suspension because of a lack of processing controls. The recall is limited to Tennessee.

    Product
    Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0417-2019·2019-02-06

    Progesterone Cream Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling Progesterone 10% cream due to a lack of processing controls. The product was distributed in Tennessee.

    Product
    Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0002-99
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0419-2019·2019-02-06

    Promethazine Gel Recalled by Duren Health Mart Pharmacy for Processing Control Issues

    Duren Health Mart Pharmacy is recalling Promethazine Gel 50 mg/mL due to a lack of processing controls. The affected product was distributed in Tennessee.

    Product
    Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0388-2019·2019-01-30

    5K Premium Enhancement capsules recalled for undeclared sildenafil and tadalafil

    Happy Together, Inc. is recalling 5K Premium Enhancement capsules because FDA analysis found undeclared sildenafil and tadalafil.

    Product
    5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0386-2019·2019-01-30

    Bound Tree Medical Recalls Curaplex Epi Kits Due to Incorrect Instructions

    Bound Tree Medical is recalling 339 Curaplex Epi Kits because the instructions recommend an unapproved epinephrine dosage for young children.

    Product
    Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive bandages, 1 x 3 1 Epi Generic Injection. Rx Only. Distributed by Sarnova HC, L
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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