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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4476–4500 of 8589

  • SevereFDA (Drugs)·D-1544-2016·2016-10-05

    FDA Recalls Hydroxyzine HCl Injection Due to Sterility Concerns

    Pharmacy Plus, Inc. is recalling 139 vials of Hydroxyzine HCl injection in Mississippi due to a lack of assurance of sterility.

    Product
    Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1540-2016·2016-10-05

    FDA Recalls Methylcobalamin Vials Due to Lack of Sterility Assurance

    Pharmacy Plus, Inc. is recalling Methylcobalamin 5,000mcg/ml vials due to lack of assurance of sterility. The recall affects 36 vials distributed in Mississippi.

    Product
    Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1539-2016·2016-10-05

    Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

    Pharmacy Plus, Inc. is recalling Morphine Sulfate 15mg/ml Injection due to a lack of assurance of sterility. The product was distributed in Mississippi.

    Product
    Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1533-2016·2016-10-05

    FDA Recalls Vital Care Compounder Eye Drops for Sterility Concerns

    The FDA is recalling specific lots of MOXI/DEX/KETOROLAC eye drops from Vital Care Compounder due to a lack of assurance of sterility.

    Product
    MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1535-2016·2016-10-05

    FDA Recalls Vital Care Compounder Papaverine and Prostaglandin Vials for Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Papaverine and Prostaglandin vials due to a lack of assurance of sterility.

    Product
    Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1514-2016·2016-09-28

    Sandoz Recalls Phenylephrine Injection Due to Sterility Concerns

    Sandoz Inc. is recalling specific lots of Phenylephrine HCI Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1512-2016·2016-09-28

    The Apothecary Recalls Prostaglandin and Other Medications Due to Sterility Concerns

    The Apothecary is recalling specific lots of Prostaglandin and other medications due to a lack of assurance of sterility and unsubstantiated validation of beyond-use dating.

    Product
    Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1509-2016·2016-09-28

    Calcium Gluconate Syringes Recalled Due to Sterility Assurance Concerns

    The Apothecary is recalling Calcium Gluconate syringes due to unsubstantiated validation of beyond use dating and lack of sterility assurance.

    Product
    Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1510-2016·2016-09-28

    The Apothecary Recalls Sterile Medications Due to Sterility Assurance Issues

    The Apothecary is recalling unexpired lots of Papaverine, Phentolamine, Calcium Gluconate, and Prostaglandin medications due to unsubstantiated validation of beyond use dating and lack of sterility assurance.

    Product
    Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1513-2016·2016-09-28

    Sandoz Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Sandoz Inc. is recalling specific lots of Ephedrine Sulfate Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1508-2016·2016-09-28

    The Apothecary Recalls Calcium Gluconate IV Bags Due to Sterility Concerns

    The Apothecary is recalling Calcium Gluconate IV bags because the pharmacy could not verify that the products remained sterile for their labeled duration.

    Product
    Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1511-2016·2016-09-28

    The Apothecary Recalls Sterile Injection Medications Due to Sterility Assurance Concerns

    The Apothecary is recalling unexpired lots of sterile injection medications due to unsubstantiated validation of beyond-use dating, which raises concerns about sterility.

    Product
    Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1500-2016·2016-09-21

    Hospira Recalls Dobutamine Injection Vials Due to Discoloration and Particulates

    Hospira Inc. is recalling 24,000 vials of Dobutamine Injection due to reports of product discoloration and particulates. The affected lot was distributed nationwide and to Puerto Rico and the Bahamas.

    Product
    DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1487-2016·2016-09-14

    Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules

    Amerisource Health Services is recalling 126 cartons of amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain multiple capsules.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Pa
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1495-2016·2016-09-14

    Teva Recalls Linezolid Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 92,480 containers of Linezolid Injection 600 mg/300 mL due to CGMP deviations. The recall covers products distributed nationwide and in Puerto Rico.

    Product
    Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1482-2016·2016-09-14

    Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors

    Amerisource Health Services is recalling 2,276 cartons of 10 mg amphetamine tablets because blister cavities may contain more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1498-2016·2016-09-14

    Allergy Laboratories Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Allergy Laboratories is recalling Ephedrine Sulfate Injection vials because an FDA inspection raised concerns about product sterility.

    Product
    Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1489-2016·2016-09-14

    Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules

    Amerisource Health Services is recalling 115 cartons of 25 mg amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health P
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2016·2016-08-31

    Talon Compounding Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Talon Compounding Pharmacy is recalling Sermorelin and Sermorelin/GHRP-2 injections because the FDA cannot assure the products are sterile.

    Product
    Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1466-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Package
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1467-2016·2016-08-31

    Mylan Amlodipine Besylate Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1468-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx
    Category
    Drug
    Distribution
    Distributed nationwide