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

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

8776–8800 of 17772

  • SevereFDA (Drugs)·D-0333-2019·2018-12-26

    Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Syringes

    Pharmedium Services, LLC is voluntarily recalling 295 syringes of a fentanyl and ropivacaine injection that were found to be sub-potent.

    Product
    Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0337-2019·2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of Infants' Ibuprofen because they may contain a higher concentration of the active ingredient.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0338-2019·2018-12-26

    Gordon Laboratories Recalls Monsel's Solution Due to High Iron Levels

    Gordon Laboratories is recalling specific batches of Monsel's (Ferric Subsulfate) Solution because they contain higher levels of iron than labeled.

    Product
    Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0336-2019·2018-12-26

    Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

    Tris Pharma is recalling 19,488 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.

    Product
    Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0335-2019·2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of infants' ibuprofen oral suspension because they may contain a higher concentration of the active ingredient.

    Product
    infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1207-2019·2018-12-26

    Sun Pharmaceutical Recalls Subpotent Absorica LD Isotretinoin Capsules

    Sun Pharmaceutical Industries is recalling Absorica LD (Isotretinoin) capsules because the active ingredient content was lower than the required specification limit.

    Product
    ABSORICA LD — ABSORICA LD (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0319-2019·2018-12-26

    GE Healthcare Recalls Omnipaque Injection Due to Vial Defect

    GE Healthcare is recalling 1,092 cartons of Omnipaque (iohexol) Injection in Tennessee due to a vial defect that could compromise sterility or introduce glass particles.

    Product
    OMNIPAQUE — OMNIPAQUE (IOHEXOL)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0382-2019·2018-12-26

    Cipla Recalls Nevirapine Extended Release Tablets for Dissolution Failure

    Cipla Limited is recalling 4,800 bottles of Nevirapine Extended Release Tablets, 400 mg, because they failed to meet dissolution specifications.

    Product
    Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0340-2019·2018-12-26

    KVK-Tech Recalls Oxybutynin Chloride Tablets Due to Wrong Bar Code

    KVK-Tech, Inc. is recalling 156 bottles of Oxybutynin Chloride Tablets, 5 mg, because they bear the wrong bar code.

    Product
    OXYBUTYNIN CHLORIDE — OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0342-2019·2018-12-26

    CBI Laboratories Recalls Subpotent Options Rx Sunscreen Tubes

    CBI Laboratories is recalling 2,055 tubes of Options Rx Anti-Oxidant Oil-Free Sunscreen because the product failed to meet specifications for active ingredient percentages.

    Product
    Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0348-2019·2018-12-26

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Failures

    VistaPharm is recalling Nystatin Oral Suspension because it failed impurity specifications. The affected product is distributed nationwide and in Puerto Rico.

    Product
    NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0330-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan Laboratories is recalling Valsartan and Hydrochlorothiazide tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0312-2019·2018-12-19

    Mylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Amlodipine and Valsartan tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0315-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling Valsartan 40 mg tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • 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-0310-2019·2018-12-19

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

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

    Product
    Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), 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-0302-2019·2018-12-19

    Westminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces

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

    Product
    Westminster Irbesartan Tablets, USP 300 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 69367-121-01; b) 90 count bottle NDC 69367-121-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0325-2019·2018-12-19

    Mylan Recalls Valsartan Tablets Due to Trace NDEA Impurity

    Mylan is recalling specific lots of Valsartan 80 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-0307-2019·2018-12-19

    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 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0322-2019·2018-12-19

    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 N-nitrosodiethylamine (NDEA) in the active ingredient.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0321-2019·2018-12-19

    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