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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551–575 of 11852

  • HighFDA (Drugs)·D-0577-2025·2025-08-20

    Carvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit

    Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0586-2025·2025-08-20

    Sodium chloride injection containers recalled over potential fluid leakage at weld site

    B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0576-2025·2025-08-20

    Amlodipine and olmesartan tablets recalled after failing dissolution specification testing

    Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0588-2025·2025-08-20

    Carvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit

    Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0556-2025·2025-08-13

    Compounded tirzepatide 6.6 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 6.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 160 vials are affected.

    Product
    Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0560-2025·2025-08-13

    Compounded tirzepatide 16.6 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 16.6 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 155 vials are affected.

    Product
    Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0558-2025·2025-08-13

    Compounded tirzepatide 11.24 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 11.24 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 146 vials are affected.

    Product
    Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0561-2025·2025-08-13

    Compounded semaglutide 0.44 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 0.44 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 221 vials are affected.

    Product
    Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0563-2025·2025-08-13

    Compounded semaglutide 1.5 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 1.5 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 190 vials are affected.

    Product
    Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0557-2025·2025-08-13

    Compounded tirzepatide 8.8 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 8.8 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 139 vials are affected.

    Product
    Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0555-2025·2025-08-13

    Compounded tirzepatide 4.4 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 4.4 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 170 vials are affected.

    Product
    Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0554-2025·2025-08-13

    Compounded tirzepatide and niacinamide vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 2.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 236 vials are affected.

    Product
    Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0566-2025·2025-08-13

    Doxepin hydrochloride capsules exceed the interim nitrosamine impurity limit

    Doxepin Hydrochloride Capsules USP 10 mg from Alembic are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 9,492 bottles affected.

    Product
    DOXEPIN HYDROCHLORIDE — DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0568-2025·2025-08-13

    Direct Rx duloxetine 30 mg capsules exceed the interim nitrosamine limit

    Duloxetine Delayed-Release 30 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 875 bottles affected.

    Product
    Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0553-2025·2025-08-13

    Compounded semaglutide 0.22 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 0.22 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 290 vials are affected.

    Product
    Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0567-2025·2025-08-13

    Duloxetine delayed-release capsules exceed the interim nitrosamine impurity limit

    Duloxetine Delayed-Release 20 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 16 bottles affected.

    Product
    Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0552-2025·2025-08-13

    Duloxetine 60 mg capsules exceed the safety assessment limit for nitrosamine

    Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0565-2025·2025-08-13

    Compounded semaglutide 2.67 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 2.67 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 158 vials are affected.

    Product
    Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0562-2025·2025-08-13

    Compounded semaglutide and cyanocobalamin vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 0.88 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 194 vials are affected.

    Product
    Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0564-2025·2025-08-13

    Compounded semaglutide 2.21 mg vials recalled over lack of processing controls

    Semaglutide + Cyanocobalamin 2.21 mg + 0.25 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 176 vials are affected.

    Product
    Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0574-2025·2025-08-13

    Spironolactone 25 mg tablets recalled after aluminum was found in product

    Spironolactone Tablets USP 25 mg are being recalled because of the presence of a foreign substance identified as aluminum. 11,328 bottles are affected.

    Product
    SPIRONOLACTONE — SPIRONOLACTONE (SPIRONOLACTONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0559-2025·2025-08-13

    Compounded tirzepatide 13.2 mg vials recalled over lack of processing controls

    Tirzepatide + Niacinamide 13.2 mg + 1.0 mg/0.5 mL injection solution compounded by Aequita Pharmacy is being recalled for lack of processing controls. 143 vials are affected.

    Product
    Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0545-2025·2025-08-06

    Bicillin L-A 2.4 million unit vials recalled after particulates found

    Bicillin L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 19,279 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0544-2025·2025-08-06

    Bicillin L-A penicillin vials recalled after particulates found during visual inspection

    Bicillin L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 50,855 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0541-2025·2025-07-30

    Budesonide inhalation ampoules recalled after leakage and empty ampoule complaint

    Budesonide Inhalation Suspension 0.5 mg/2 mL is being recalled for lack of assurance of sterility after a market complaint was received for leakage and an empty ampoule. 13,680 ampoules affected.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide