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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10101–10125 of 17785

  • SevereFDA (Drugs)·D-0150-2018·2018-01-10

    Pfizer Recalls Diphenoxylate and Atropine Tablets Due to Potency Variations

    Pfizer is recalling specific lots of diphenoxylate hydrochloride and atropine sulfate tablets because weight variations caused some tablets to be sub-potent or super-potent.

    Product
    DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE — DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0151-2018·2018-01-10

    Pfizer Recalls Zoloft Tablets Due to Weight Variations

    Pfizer is recalling 1,972 bottles of Zoloft 25 mg tablets because weight variations caused some tablets to be sub or super potent.

    Product
    Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0144-2018·2018-01-03

    SSM St. Clare Recalls Phenylephrine Syringes Due to Sterility Concerns

    SSM St. Clare Health Center is recalling compounded phenylephrine syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.

    Product
    Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0143-2018·2018-01-03

    SSM St. Clare Recalls Oxytocin IV Bags Due to Sterility Concerns

    SSM St. Clare Health Center is recalling specific lots of compounded Oxytocin IV bags due to a lack of sterility assurance. No distributed product has been identified as actually containing microorganisms.

    Product
    Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0141-2018·2018-01-03

    SSM St. Clare Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns

    SSM St. Clare Health Center is recalling compounded Neostigmine Methylsulfate syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.

    Product
    Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0138-2018·2018-01-03

    SSM St. Clare Recalls Compounded Fentanyl and Ropivacaine Injectable Bags

    SSM St. Clare Health Center is recalling compounded fentanyl and ropivacaine injectable bags due to a lack of sterility assurance. Microbial growth was detected during a routine simulation, though no distributed product was found to contain microorganisms.

    Product
    Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0142-2018·2018-01-03

    SSM St. Clare Recalls Norepinephrine IV Bags Due to Sterility Concerns

    SSM St. Clare Health Center is recalling specific lots of compounded Norepinephrine IV bags in Missouri due to microbial growth detected during a routine manufacturing simulation.

    Product
    Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0145-2018·2018-01-03

    SSM St. Clare Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    SSM St. Clare Health Center is recalling specific lots of compounded succinylcholine chloride syringes because microbial growth was detected during a routine manufacturing simulation.

    Product
    Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0139-2018·2018-01-03

    SSM St. Clare Recalls Hydromorphone PCA Cartridges Due to Sterility Concerns

    SSM St. Clare Health Center is recalling specific lots of compounded Hydromorphone PCA cartridges due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.

    Product
    HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0140-2018·2018-01-03

    SSM St. Clare Recalls Morphine PCA Cartridges Due to Sterility Concerns

    SSM St. Clare Health Center is recalling specific lots of compounded Morphine PCA cartridges due to a lack of sterility assurance detected during routine testing.

    Product
    Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0135-2018·2018-01-03

    Bayer Chewable Low Dose Aspirin Recalled for Failed Stability Specifications

    Bayer HealthCare Pharmaceuticals is recalling 104,128 bottles of Chewable Low Dose Aspirin 81 mg due to failed stability specifications.

    Product
    Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0136-2018·2018-01-03

    SSM St. Clare Recalls Fentanyl Vials Due to Sterility Assurance Concerns

    SSM St. Clare Health Center is recalling Fentanyl 10 mcg vials because microbial growth was detected during a routine manufacturing simulation. No distributed product has been identified as containing microorganisms.

    Product
    Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0137-2018·2018-01-03

    SSM St. Clare Recalls Amiodarone Injectable Due to Sterility Concerns

    SSM St. Clare Health Center is recalling a specific lot of compounded Amiodarone injectable bags due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.

    Product
    Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0133-2018·2018-01-03

    Auryxia Ferric Citrate Tablets Recalled for Damaged Desiccant Packets

    Keryx Biopharmaceuticals is recalling Auryxia (ferric citrate) tablets because damaged silica gel packets may allow desiccant granules to contact the medication.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0131-2018·2018-01-03

    Pharmedium Recalls Morphine Sulfate Injection Due to Labeling Errors

    Pharmedium Services LLC is recalling specific lots of compounded morphine sulfate injection because the labels may have incorrect or missing lot and expiration dates.

    Product
    morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0130-2018·2018-01-03

    Pharmedium Recalls Morphine Sulfate Injection Due to Labeling Errors

    Pharmedium Services LLC is recalling morphine sulfate injection due to incorrect or missing lot and expiration dates on the labels.

    Product
    morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0132-2018·2018-01-03

    Pharmedium Recalls Hydromorphone Injection Due to Labeling Errors

    Pharmedium Services LLC is recalling Hydromorphone HCl Injection due to incorrect or missing lot and expiration dates.

    Product
    HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0123-2018·2017-12-27

    Pfizer Recalls Vancomycin Hydrochloride Vials Due to Glass Particulate Matter

    Pfizer Inc. is recalling 102,500 vials of Vancomycin Hydrochloride for Injection due to the presence of glass particulate matter.

    Product
    VANCOMYCIN HYDROCHLORIDE — VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0126-2018·2017-12-27

    FDA Recalls Natural Herbal Coffee AMPT for Undeclared Sildenafil and Tadalafil

    The FDA is recalling Natural Herbal Coffee AMPT because it contains undeclared sildenafil, tadalafil, and milk. The product was marketed without an approved NDA or ANDA.

    Product
    NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0122-2018·2017-12-27

    LaBri's Body Health XPLODE Recalled for Unapproved Sibutramine

    EZWeightLossTX LLC is recalling LaBri's Body Health XPLODE capsules because they contain sibutramine, an unapproved drug ingredient.

    Product
    LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0115-2018·2017-12-27

    Advanced Pharma Recalls Subpotent Nitroglycerin Injection Syringes

    Advanced Pharma Inc. is recalling Nitroglycerin injection syringes found to be subpotent, meaning they contain less active ingredient than labeled.

    Product
    NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0121-2018·2017-12-27

    FDA Recalls LaBri's Body Health Atomic 60 Capsules for Sibutramine Contamination

    EZWeightLossTX LLC is recalling LaBri's Body Health Atomic 60 Capsules because the product was found to contain sibutramine, an unapproved drug ingredient.

    Product
    LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0120-2018·2017-12-27

    Amneal Recalls Lorazepam Oral Concentrate Due to Defective Dropper Markings

    Amneal Pharmaceuticals is recalling Lorazepam Oral Concentrate because dropper measurement markings may be reversed, shifted, or missing, which could lead to dosing errors.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0113-2018·2017-12-27

    Advanced Pharma Recalls Subpotent NitroGlycerin Injection Syringes Nationwide

    Advanced Pharma Inc. is recalling 550 syringes of NitroGlycerin injection found to be subpotent. The product was distributed nationwide to hospitals and medical facilities.

    Product
    NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0114-2018·2017-12-27

    Advanced Pharma Recalls Subpotent Nitroglycerin Injection Syringes

    Advanced Pharma Inc. is recalling 320 syringes of Nitroglycerin injection that were found to be subpotent, meaning they contain less active ingredient than labeled.

    Product
    NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.
    Category
    Drug
    Distribution
    Distributed nationwide