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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

2901–2925 of 18005

  • ModerateFDA (Drugs)·D-0515-2023·2023-04-12

    Doxazosin Tablets Recalled Due to Manufacturing Process Deviations

    Preferred Pharmaceuticals is recalling Doxazosin Tablets, USP, 4 mg (lot L1522V, expiration 4/30/2025) due to current Good Manufacturing Practice deviations discovered during FDA inspection of the manufacturer, Accord Healthcare. The product was distributed nationwide.

    Product
    Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2023·2023-04-12

    Rosuvastatin 5mg Tablets Recalled Due to Manufacturing Deviations

    RemedyRepack Inc. voluntarily recalled 132 bottles of Rosuvastatin 5mg tablets nationwide due to current Good Manufacturing Practice deviations. No illnesses or injuries have been reported.

    Product
    Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2023·2023-04-12

    Alprazolam 1 mg tablets recalled due to manufacturing contamination concerns

    Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.

    Product
    Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0481-2023·2023-04-05

    FDA Recalls Glimepiride Tablets Due to Manufacturing Quality Violations

    Direct Rx is voluntarily recalling Glimepiride 2 mg tablets nationwide due to manufacturing practice violations. The recall affects multiple lot numbers of 30-count and 90-count bottles distributed across the United States.

    Product
    Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0487-2023·2023-04-05

    Apollo Care Fentanyl and Ropivacaine Epidural Injection Recalled for Contamination

    Apollo Care is recalling 215 bags of Fentanyl and Ropivacaine epidural injection (Lot AC-016581) due to suspected microbial growth on external packaging. The recall affects product distributed in Missouri.

    Product
    Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0475-2023·2023-04-05

    Calcitonin Salmon Nasal Spray Recalled for Out-of-Specification Impurities and Low Potency

    Endo Pharmaceuticals is recalling Calcitonin Salmon Nasal Spray due to out-of-specification impurities and subpotent drug content. Affected lots distributed nationwide have expiration dates ranging from March 2023 to March 2025.

    Product
    CALCITONIN SALMON — CALCITONIN SALMON (CALCITONIN SALMON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0533-2023·2023-04-05

    Dabigatran Etexilate Drug Recalled Due to N-nitroso Impurity

    Ascend Laboratories is recalling 13,560 bottles of Dabigatran Etexilate 75 mg capsules nationwide because testing detected N-nitroso-dabigatran impurity levels above acceptable limits. The issue stems from a manufacturing quality control deviation.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0534-2023·2023-04-05

    Prescription Drug Dabigatran Etexilate Recalled for Excess Nitrosamine Impurity

    Ascend Laboratories is recalling 12,804 bottles of Dabigatran Etexilate 150mg capsules nationwide due to detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake limit caused by manufacturing process deviations.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0479-2023·2023-04-05

    Ropinirole 1 mg Tablets Recalled Nationwide for Manufacturing Process Deviations

    Direct Rx is recalling Ropinirole 1 mg tablets nationwide due to manufacturing process deviations. Consult a pharmacist before stopping this medication.

    Product
    Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2023·2023-04-05

    Drug Recall: Simvastatin 5 mg tablets due to manufacturing compliance violations

    Direct Rx is recalling 51 bottles of Simvastatin 5 mg tablets nationwide due to Good Manufacturing Practice deviations. The recall is voluntary and was initiated in March 2023.

    Product
    Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0476-2023·2023-04-05

    Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Montelukast Sodium 10 mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects approximately 508 bottles distributed across the United States.

    Product
    Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2023·2023-04-05

    Drug Recall: Glimepiride Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Glimepiride, USP, 1 mg Tablets nationwide due to cGMP deviations. The firm-initiated recall impacts both 30-count and 90-count bottles distributed across the USA.

    Product
    Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2023·2023-04-05

    Simvastatin 20mg Tablets Recalled for Manufacturing Practice Deviations

    Direct Rx recalled Simvastatin 20mg tablets nationwide due to manufacturing practice deviations. The voluntary recall affects bottles distributed across the United States.

    Product
    Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0482-2023·2023-04-05

    Glimepiride tablet recall due to manufacturing practice deviations

    Direct Rx is recalling Glimepiride 4 mg tablets nationwide due to manufacturing process deviations. The recall is voluntary and affects specific lots of 30-count and 90-count bottles.

    Product
    Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2023·2023-04-05

    Prescription Drug Ropinirole 0.25 mg Tablets Recalled for Manufacturing Deviations

    Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets (NDC 72189-0364-30, Lot 21JU2210) nationwide due to Good Manufacturing Practice (cGMP) deviations. The firm voluntarily initiated this recall on March 13, 2023.

    Product
    Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0484-2023·2023-04-05

    Drug Manufacturer Recalls Simvastatin Tablets for Manufacturing Deviations

    Direct Rx recalled Simvastatin 10 mg tablets nationwide due to manufacturing process deviations discovered during production. No illnesses or injuries have been reported.

    Product
    Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2023·2023-04-05

    Simvastatin Tablets Recalled Nationwide Over Manufacturing Practice Deviations

    Direct Rx is recalling 269 bottles of Simvastatin 40 mg nationwide due to Good Manufacturing Practice deviations. No adverse events have been reported. Consult your healthcare provider before changing your medication.

    Product
    Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0477-2023·2023-04-05

    Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations

    Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.

    Product
    Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0488-2023·2023-03-29

    Delsam Pharma Artificial Eye Ointment Recalled for Bacterial Contamination

    Delsam Pharma's Artificial Eye Ointment is being recalled for bacterial contamination in unopened tubes. FDA analysis found non-sterility defects in approximately 50,000 units.

    Product
    Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0472-2023·2023-03-29

    Daytrana methylphenidate patches recalled for defective delivery system

    Noven Pharmaceuticals is recalling Daytrana methylphenidate transdermal patches for a defective delivery system that fails to meet shear specifications. The recall affects specific lots distributed nationwide.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0473-2023·2023-03-29

    Daytrana Methylphenidate Transdermal Patches Recalled for Defective Delivery System

    Noven Pharmaceuticals recalls Daytrana (methylphenidate) 30 mg transdermal patches nationwide due to defective delivery system components that fail shear specifications. Patients should contact their healthcare provider regarding medication alternatives.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0468-2023·2023-03-29

    Prescription Drug Recall: Jardiance Empagliflozin 25 mg Label Mix-Up

    Boehringer Ingelheim Pharmaceuticals is recalling Jardiance (Empagliflozin) 25 mg tablets due to a label mix-up affecting 69,375 bottles distributed nationwide.

    Product
    JARDIANCE — JARDIANCE (EMPAGLIFLOZIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0471-2023·2023-03-29

    Daytrana Methylphenidate Patches Recalled for Defective Transdermal Delivery System

    Noven Pharmaceuticals is recalling specific lots of Daytrana (methylphenidate) transdermal patches due to a defective delivery system that is out of specification for shear. Affected lots are Lot 91956 (6/2023) and Lot 92475 (7/2023), distributed nationwide.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0474-2023·2023-03-29

    Dofetilide Capsules Recalled for Failed Content Uniformity Specifications

    Sun Pharmaceutical is recalling 1,920 bottles of Dofetilide Capsules (500 mcg) nationwide due to failed content uniformity specifications, meaning the capsules do not contain uniform amounts of active ingredient.

    Product
    Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0470-2023·2023-03-29

    Daytrana Methylphenidate Patches Recalled for Defective Delivery System

    Noven Pharmaceuticals is recalling specific lots of Daytrana methylphenidate transdermal patches distributed nationwide because the delivery system is out of specification for shear. The affected lots require patient and healthcare provider attention.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide