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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8976–9000 of 18015

  • SevereFDA (Drugs)·D-0327-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Valsartan 320 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0309-2019·2018-12-19

    Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACE
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0300-2019·2018-12-19

    Westminster Irbesartan Tablets Recalled Due to NDEA Impurity

    Westminster Pharmaceuticals is recalling specific lots of Irbesartan tablets because FDA testing found traces of the NDEA impurity.

    Product
    Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-119-01; b) 90 count bottle NDC 69367-119-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0323-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity NDEA in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0296-2019·2018-12-19

    LGM Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    LGM Pharma LLC is recalling 1,307 kg of Thyroid Powder, USP, because the product has inconsistent levels of active ingredients levothyroxine and liothyronine.

    Product
    Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0290-2019·2018-12-19

    CAO Group Recalls fas.TRACT Hemostatic Gel Due to cGMP Violations

    CAO Group, Inc. is recalling fas.TRACT Coagulative Hemostatic Gel kits due to current Good Manufacturing Practice (cGMP) violations identified during a recent inspection.

    Product
    fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0295-2019·2018-12-19

    QuVa Pharma Recalls Norepinephrine Injection Bags Due to Incorrect Excipient

    QuVa Pharma is recalling 168 bags of Norepinephrine Injection compounded in 5% Dextrose instead of 0.9% Sodium Chloride. The product was distributed in California.

    Product
    Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0294-2019·2018-12-19

    Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure

    Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate 300 mg tablets because they failed dissolution specifications during stability testing.

    Product
    CLOPIDOGREL BISULFATE — CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0292-2019·2018-12-19

    CAO Group Recalls BeeGentle Topical Anesthetic Due to cGMP Violations

    CAO Group, Inc. is recalling BeeGentle Honey Flavored Topical Anesthetic because of current Good Manufacturing Practice (cGMP) violations found during a recent FDA inspection.

    Product
    BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Me
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0291-2019·2018-12-19

    CAO Group Recalls SHEER DesenZ Desensitizing Treatment Due to cGMP Violations

    CAO Group, Inc. is recalling SHEER DesenZ Desensitizing Treatment because cGMP violations were noted during the firm's most recent inspection.

    Product
    SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0293-2019·2018-12-19

    CAO Group Recalls FastStat Topical Hemostat Kits Due to cGMP Violations

    CAO Group, Inc. is recalling FastStat Topical Hemostat Introductory Kits because cGMP violations were noted during the firm's most recent inspection.

    Product
    FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0299-2019·2018-12-12

    Fresenius Kabi Recalls Sodium Chloride Vials Due to Incorrect Latex Labeling

    Fresenius Kabi is recalling 1,312,350 vials of Sodium Chloride Injection because labels incorrectly state the stoppers do not contain natural rubber latex.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0289-2019·2018-12-12

    Aurobindo Recalls Amlodipine and Olmesartan Medoxomil Tablets Due to Discoloration

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Olmesartan Medoxomil tablets because they were found to be pink instead of the expected cream color.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0359-2019·2018-12-05

    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets Recalled for NDEA Impurity

    Sandoz is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0287-2019·2018-12-05

    Ascend Recalls Quetiapine Tablets Due to Metal Shard Contamination

    Ascend Laboratories is recalling Quetiapine 400 mg tablets because a metal shard was found in a tablet. Patients should stop using the affected lot and contact their healthcare provider.

    Product
    QUETIAPINE — QUETIAPINE (QUETIAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0285-2019·2018-12-05

    Germ Bloc Health Hand Sanitizer Foam Recalled for Pseudomonas Contamination

    AVKARE Inc. is recalling specific lots of Germ Bloc Health Hand Sanitizer Foam due to the presence of Pseudomonas aeruginosa.

    Product
    Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1208-2019·2018-12-05

    Akorn Recalls Clindamycin Phosphate Topical Solution Due to Impurity Failures

    Akorn, Inc. is recalling 58,393 jars of Clindamycin Phosphate Topical Solution USP, 1% because the product failed impurity and degradation specifications.

    Product
    Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0282-2019·2018-12-05

    Allergan Recalls INFed Iron Dextran Injection for Stability Failure

    Allergan is recalling INFed (Iron Dextran Injection) vials because they failed stability specifications for iron content. The product was distributed throughout the United States.

    Product
    INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0284-2019·2018-12-05

    RemedyRepack Recalls Nitrofurantoin Capsules Due to Cross-Contamination

    RemedyRepack Inc. is recalling specific lots of Nitrofurantoin Monohydrate/Macrocrystals capsules due to potential cross-contamination with unrelated ingredients.

    Product
    Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard tra
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0264-2019·2018-11-28

    Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

    Golden State Medical Supply is recalling Irbesartan 150 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0265-2019·2018-11-28

    Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

    Golden State Medical Supply is recalling 12,502 bottles of Irbesartan 300 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0270-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 75 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0263-2019·2018-11-28

    FDA Recalls Irbesartan Tablets Due to NDEA Impurity

    Golden State Medical Supply Inc. is recalling 2,439 bottles of Irbesartan 75 mg tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0271-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
    Category
    Drug
    Distribution
    Distributed nationwide