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

8926–8950 of 18015

  • ModerateFDA (Drugs)·D-0344-2019·2019-01-02

    Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures

    Amerigen Pharmaceuticals is recalling specific lots of Temozolomide Capsules because they failed to meet dissolution specifications.

    Product
    Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0345-2019·2019-01-02

    Amerigen Recalls Temozolomide Capsules for Failed Dissolution Specifications

    Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 180 mg, due to failed dissolution specifications. The FDA classified this as a Class III recall.

    Product
    Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0360-2019·2018-12-26

    Lubrisine eye drops recalled for undeclared colloidal silver and sterility issues

    Results RNA, LLC is recalling Lubrisine eye drops nationwide due to lack of sterility assurance and the presence of undeclared colloidal silver.

    Product
    Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2019·2018-12-26

    Pharmedium Recalls Sub-Potent Fentanyl and Ropivacaine Injection Bags

    Pharmedium Services, LLC is voluntarily recalling 295 bags of Fentanyl Citrate and Ropivacaine HCl injection because the product was found to be sub-potent.

    Product
    Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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
  • 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-0354-2019·2018-12-26

    Enovachem Recalls Dyural-80 Injection Kits Due to Incorrect Latex Labeling

    Enovachem is recalling Dyural-80 Injection Kits because the product insert incorrectly stated that the stoppers do not contain latex, when they actually contain natural rubber latex.

    Product
    Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
    Category
    Drug
    Distribution
    0 states
  • 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-0353-2019·2018-12-26

    Dyural-40 Injection Kit Recalled for Incorrect Latex Labeling

    Asclemed USA Inc. is recalling Dyural-40 Injection Kits because the product insert incorrectly states that the stoppers do not contain latex, when they actually do.

    Product
    Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0343-2019·2018-12-26

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 85 vials of Human Chorionic Gonadotropin 3000 IU due to inadequate processes to assure sterility.

    Product
    Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
    Category
    Drug
    Distribution
    1 state
  • 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
  • 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
  • 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-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-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
  • 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
  • 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
  • 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-0329-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

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

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • 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