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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7301–7325 of 11823

  • 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-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
  • HighFDA (Drugs)·D-1462-2016·2016-08-31

    Talon Compounding Pharmacy Recalls Human Chorionic Gonadotropin Injection Due to Sterility Concerns

    Talon Compounding Pharmacy is recalling 6,500 vials of Human Chorionic Gonadotropin Injection nationwide due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g) 7500 iu, (h) 7500 iu with B12, (i)11,000 iu, (j)11,000 iu with B12, (k) 15,000 iu, (l) 20,000 iu, (m) 20,000 iu with B12, 10 mL sterile, dep
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1458-2016·2016-08-24

    Golden State Medical Supply Recalls Venlafaxine Hydrochloride Extended-Release Capsules

    Golden State Medical Supply Inc. is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, due to failed dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1456-2016·2016-08-17

    Spectrum Chemical Recalls Zinc Acetate Due to Excess Lead Levels

    Spectrum Laboratory Products is recalling Zinc Acetate, Crystal, USP, because it contains lead levels exceeding USP monograph limits.

    Product
    Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1455-2016·2016-08-17

    Teva Recalls Albuterol Sulfate Syrup Due to Foreign Particles

    Teva North America is recalling 8,052 bottles of Albuterol Sulfate Syrup because black particles were found in the product.

    Product
    Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1452-2016·2016-08-10

    Let's Talk Health Recalls Unapproved Oxygen Nasal Wash Solution

    Let's Talk Health is recalling 417 bottles of Oxygen Nasal Wash because the product was marketed without FDA approval and does not comply with nasal decongestant monograph requirements.

    Product
    Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1447-2016·2016-08-03

    Medicap Pharmacy Recalls Acetylcyst 10% Ophthalmic Solution for Sterility Concerns

    Medicap Pharmacy is recalling Acetylcyst 10% Ophthalmic Solution because sterile products were not produced in a controlled, sterile environment.

    Product
    Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1433-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate

    PharMEDium Services, LLC is recalling 79 syringes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the active pharmaceutical ingredient.

    Product
    6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1396-2016·2016-07-27

    FDA Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates

    Pharmedium Services is recalling 97,716 bags of sterile injectable fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1363-2016·2016-07-27

    PharMEDium Recalls Morphine and Bupivacaine Bags Due to Glass Particulates

    PharMEDium Services is recalling 15 bags of compounded morphine and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    0.1 mg/mL Morphine Sulfate and 0.05% Bupivacaine HCI (Preservative Free) in 0.9%, 150 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9994 , Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-994-83
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1397-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulate

    Pharmedium Services, LLC is recalling 250 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution because the active pharmaceutical ingredient was contaminated with glass particulate.

    Product
    2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1382-2016·2016-07-27

    FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate

    PharMEDium Services is recalling 740 syringes of compounded fentanyl and bupivacaine because glass particulate was found in the active ingredient.

    Product
    10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1386-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate

    PharMEDium Services, LLC is recalling 1,234 cassettes of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

    Product
    10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1445-2016·2016-07-27

    GlaxoSmithKline Recalls Bactroban Ointment Due to Penicillin Cross-Contamination

    GlaxoSmithKline is recalling 18,000 tubes of Bactroban Ointment because of penicillin cross-contamination. The affected product is distributed nationwide and in Puerto Rico.

    Product
    Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1413-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services is recalling 700 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1425-206·2016-07-27

    FDA Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate Matter

    PharMEDium Services is recalling 2,713 syringes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.

    Product
    5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1416-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate

    Pharmedium Services is recalling 5,727 sterile injectable cassettes containing fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate.

    Product
    3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Co
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1381-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate

    Pharmedium Services is recalling specific lots of compounded fentanyl and bupivacaine syringes because the active ingredient was contaminated with glass particulate matter.

    Product
    10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium Serv
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1379-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    Pharmedium Services, LLC is recalling 750 bags of compounded Fentanyl Citrate and Bupivacaine HCl injectable solution distributed nationwide due to the presence of glass particulate matter.

    Product
    10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1380-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Injectable Due to Glass Particulate

    Pharmedium Services, LLC is recalling specific lots of compounded Fentanyl Citrate and Bupivacaine HCl injectable solutions because they were produced using an API contaminated with glass particulate matter.

    Product
    10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1422-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services is recalling 655 bags of compounded fentanyl and bupivacaine injectable solutions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.

    Product
    5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1405-2016·2016-07-27

    FDA Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services is recalling 2,006 bags of compounded fentanyl and bupivacaine injectable drugs because the active ingredient was contaminated with glass particulate matter.

    Product
    2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1401-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    PharMEDium Services is recalling 90 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1369-2016·2016-07-27

    PharMEDium Recalls Sufentanil and Bupivacaine Bags Due to Glass Particulates

    PharMEDium Services is recalling 140 bags of compounded sufentanil and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free), 150 mL in 150 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-713-95
    Category
    Drug
    Distribution
    Distributed nationwide