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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10701–10725 of 17785

  • SevereFDA (Drugs)·D-0784-2017·2017-05-24

    Key Pharmacy Recalls Vitamin B Complex Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Vitamin B Complex injections because the firm cannot guarantee the products are sterile.

    Product
    VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0728-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.

    Product
    HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0755-2017·2017-05-24

    Key Pharmacy Recalls Quad Mix Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Quad Mix 50/30/1/0.2 injection because the firm cannot assure the sterility of the product.

    Product
    QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0723-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Hydroxo-B12 inhalation solution because the firm cannot assure the sterility of the product.

    Product
    HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0781-2017·2017-05-24

    Key Pharmacy Recalls SOD Phenylbutyrate Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 91 vials of SOD Phenylbutyrate injections due to a lack of assurance of sterility.

    Product
    SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0734-2017·2017-05-24

    Key Pharmacy Recalls Compounded PGE1/PAP Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of compounded PGE1/PAP injection because the firm cannot assure the sterility of the product.

    Product
    PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0708-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL multiple-dose vials due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0738-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Drug Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 10/30/1 injection due to a lack of assurance of sterility.

    Product
    TRI MIX 10/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0757-2017·2017-05-24

    Key Pharmacy Recalls PGE1/Procaine Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injection because the firm cannot ensure the sterile compounded drugs are free from contamination.

    Product
    PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0722-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the products.

    Product
    HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0772-2017·2017-05-24

    Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 1% injections because the firm cannot ensure the products are sterile.

    Product
    PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0785-2017·2017-05-24

    Key Pharmacy Recalls Vitamin D3 Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Vitamin D3 in Olive Oil SDV 100,000U/mL Injection due to a lack of assurance of sterility.

    Product
    VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0790-2017·2017-05-24

    Taro Recalls Fluocinonide Cream Due to Hydrocortisone Contamination

    Taro Pharmaceuticals is recalling specific lots of Fluocinonide Cream 0.05% due to cross-contamination with hydrocortisone-17-valerate.

    Product
    FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0787-2017·2017-05-24

    Teligent Recalls Desoximetasone Ointment Due to Superpotent Drug Classification

    Teligent, Inc. is voluntarily recalling 3,600 tubes of Desoximetasone Ointment 0.25% in Tennessee due to a superpotent drug classification.

    Product
    Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0705-2017·2017-05-17

    Teva Recalls Clozapine Tablets Due to Microbial Contamination

    Teva Pharmaceuticals is recalling specific lots of Clozapine Tablets USP, 25 mg, due to microbial contamination of non-sterile products.

    Product
    Clozapine Tablets USP, 25 mg, 100-count bottle (NDC 0093-4359-01), 500- count bottle (NDC 0093-4359-05), 100 Unit Dose Blisters per carton (NDC 0093-4359-93), Individual Blister Pack (NDC 0093-4359-19), Rx Only, Manufactured By: Teva Pharmaceutical Industries Ltd., Jerusalem, 977
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0702-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 20 mg, because they failed impurity specifications. The recall covers 14,784 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Olanzapine Tablets, 2.5 mg, because they failed impurity specifications.

    Product
    Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0700-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 7.5 mg, because they failed impurity specifications. The recall covers 6,138 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceut
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0701-2017·2017-05-17

    Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 10 mg, because they failed impurity specifications. The recall covers 38,316 bottles distributed nationwide and in Puerto Rico.

    Product
    Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0703-2017·2017-05-17

    Teva Recalls Prednisolone Oral Solution for Failed Stability Specifications

    Teva Pharmaceuticals USA is recalling specific lots of Prednisolone Oral Solution because they failed stability specifications.

    Product
    PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0697-2017·2017-05-17

    Akorn Recalls IC-Green Injection Kits Due to Low pH Value

    Akorn, Inc. is recalling 1,292 kits of IC-Green (indocyanine green for injection) due to low pH values. The product was distributed nationwide.

    Product
    IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0690-2017·2017-05-10

    EpiPen Auto-Injectors Recalled for Defective Delivery System

    Meridian Medical Technologies is recalling EpiPen auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.

    Product
    EPIPEN — EPIPEN (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0691-2017·2017-05-10

    EpiPen Jr. Auto-Injectors Recalled for Delivery System Defects

    Meridian Medical Technologies is recalling EpiPen Jr. auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.

    Product
    EPIPEN — EPIPEN (EPINEPHRINE)
    Category
    Drug
    Distribution
    Distributed nationwide