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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7326–7350 of 11856

  • 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-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-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-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-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-1374-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulates

    Pharmedium Services, LLC is recalling 361 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1419-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates

    Pharmedium Services is recalling 3,828 syringes of compounded fentanyl and bupivacaine because the active ingredient was contaminated with glass particulate matter.

    Product
    4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1430-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated With Glass Particulate

    PharMEDium Services is recalling 90 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

    Product
    5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8233, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-233-54
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1420-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate

    Pharmedium Services, LLC is recalling 936 cassettes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the sterile injectable solution.

    Product
    4 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, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 6155
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1417-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    Pharmedium Services, LLC is recalling 1,015 bags of compounded fentanyl and bupivacaine injectable solutions because the active ingredient was contaminated with glass particulate matter.

    Product
    3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1392-2016·2016-07-27

    FDA Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulate

    PharMEDium Services is recalling 950 bags of compounded fentanyl and bupivacaine infusions because glass particulate was found in the active pharmaceutical ingredient.

    Product
    2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1373-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates

    PharMEDium Services is recalling specific lots of compounded fentanyl and bupivacaine infusions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.

    Product
    1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1434-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

    PharMEDium Services is recalling 650 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

    Product
    8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1377-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Cassettes Due to Glass Particulate

    PharMEDium Services, LLC is recalling 384 cassettes of Fentanyl Citrate and Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.

    Product
    1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1383-2016·2016-07-27

    Pharmedium Recalls Hydrocodone and Bupivacaine Bags Due to Glass Particulate

    Pharmedium Services is recalling 55 bags of compounded sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

    Product
    10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1362-2016·2016-07-27

    PharMEDium Recalls Bupivacaine HCl Due to Glass Particulate Contamination

    PharMEDium Services, LLC is recalling 2,194 bags and cassettes of 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride because the active pharmaceutical ingredient was contaminated with glass particulate matter.

    Product
    0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), b) 250 mL Hospira LifeCare Bag (NDC 61553-197-50), c) 150 mL Baxter Intravia Bag (NDC 61553-189-48), d) 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02), e) 250 mL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1360-2016·2016-07-27

    Pharmedium Recalls Bupivacaine HCl Due to Glass Particulate Contamination

    Pharmedium Services, LLC is recalling 177 cassettes of 0.03% Bupivacaine HCl because the active ingredient was contaminated with glass particulate matter.

    Product
    0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1431-2016·2016-07-27

    FDA Recalls Hydrocodone and Bupivacaine Syringes Due to Glass Particulates

    PharMEDium Services is recalling 5 syringes of compounded hydrocodone and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20
    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-1412-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

    PharMEDium Services, LLC is recalling 555 sterile injectable drug cassettes containing Hydromorphone HCl and Bupivacaine HCl due to the presence of glass particulate matter.

    Product
    20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
    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