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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3976–4000 of 18005

  • HighFDA (Devices)·Z-1157-2022·2022-06-08

    I.V. Start Kit Recall Due to Uncertain Manufacturing Process Validation

    Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.

    Product
    I.V. Start Kit Catalog 8172
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0971-2022·2022-06-08

    Blood Pressure Medication Losartan-HCTZ Recalled for Impurity Deviation

    Direct Rx is recalling 81 bottles of Losartan Potassium and Hydrochlorothiazide 100/12.5 mg due to AZIDO impurity exceeding acceptable manufacturing standards. Affected bottles were distributed in Alabama, Georgia, Florida, and Louisiana.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0961-2022·2022-06-08

    Injectable Labetalol HCl Syringes Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center has recalled 115,640 units of Labetalol HCl Injection due to lack of assurance of sterility. The affected product was distributed nationwide.

    Product
    Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2022·2022-06-08

    Busse Convenience Kits Recalled Due to Manufacturing Test Validation Issue

    Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.

    Product
    SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0968-2022·2022-06-08

    Rocuronium Bromide Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection pre-filled syringes nationwide due to lack of sterility assurance. Approximately 604,080 syringes are affected.

    Product
    Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0950-2022·2022-06-08

    Sodium Bicarbonate Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling approximately 13,612 units of 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL Pre-Filled Syringe, packaged in a) 10 x 1 syringe carton, b) 30 x 1 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0967-2022·2022-06-08

    Phenylephrine HCl Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide because the manufacturer cannot assure the product met sterility standards required for injectable medications.

    Product
    Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0976-2022·2022-06-08

    AMBI Skincare Fade Cream Recalled for Temperature Storage Deviations

    AMBI Skincare Fade Cream is being recalled nationwide due to cGMP violations. The product was stored outside its labeled temperature requirements during manufacturing.

    Product
    AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0962-2022·2022-06-08

    Lidocaine Injectable Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.

    Product
    Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-FIlled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0965-2022·2022-06-08

    Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were distributed nationwide.

    Product
    Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-955-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0964-2022·2022-06-08

    Oxytocin Injectable Drug Recalled for Lack of Sterility

    Nephron Sterile Compounding Center has recalled 3,587 bags of Oxytocin injectable nationwide due to lack of assurance of sterility.

    Product
    Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP, 500 mL Single-Dose Container Bag, 10 x 1 IV Bag, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-543-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0951-2022·2022-06-08

    Calcium Gluconate Injection Syringes Recalled for Sterility Assurance

    Nephron Sterile Compounding Center is recalling 30,180 pre-filled Calcium Gluconate Injection syringes due to lack of sterility assurance. Affected lots CG1003A and CG2001A were distributed nationwide.

    Product
    Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-950-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0966-2022·2022-06-08

    Phenylephrine HCl Injection recalled for lack of sterility assurance

    Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide due to lack of assurance of sterility affecting 76,860 units.

    Product
    Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0973-2022·2022-06-08

    Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels

    Strides Pharma Inc. is recalling Losartan Potassium 50 mg tablets distributed nationwide due to AZIDO impurity levels exceeding acceptable FDA manufacturing standards.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0955-2022·2022-06-08

    Glycopyrrolate Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.

    Product
    Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0952-2022·2022-06-08

    EPINEPHrine Pre-filled Syringes Recalled for Sterility Assurance Issue

    Nephron Sterile Compounding Center is recalling 35,850 pre-filled syringes of EPINEPHrine Injection due to lack of sterility assurance. The affected syringes were distributed nationwide.

    Product
    EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-544-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0956-2022·2022-06-08

    Glycopyrrolate Injection Recalled Due to Lack of Sterility Assurance

    Nephron is recalling 6,150 units of Glycopyrrolate Injection due to lack of sterility assurance. Healthcare providers should stop using affected lots and contact their supplier for return instructions.

    Product
    Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0963-2022·2022-06-08

    Neostigmine Methylsulfate Injection Recalled Due to Sterility Assurance Failure

    Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The compounded injectable drug may not meet sterile product standards.

    Product
    Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0974-2022·2022-06-08

    Losartan Potassium Tablets Recalled for CGMP Deviations and Elevated Impurity

    Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0960-2022·2022-06-08

    Ketamine Hydrochloride Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Ketamine Hydrochloride Injection due to lack of assurance of sterility. The recall affects 107,530 pre-filled syringes distributed nationwide.

    Product
    Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2022·2022-06-08

    Swab drug products recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0957-2022·2022-06-08

    Hydromorphone Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection 50 mg/50 mL pre-filled syringes due to lack of sterility assurance. The recalled product was distributed nationwide.

    Product
    Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x 50 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0969-2022·2022-06-08

    Succinylcholine Chloride Injection Recalled Due to Lack of Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.

    Product
    Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-920-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2022·2022-06-08

    Busse Convenience Kits Recalled: Drug Swabs Face Manufacturing Validation Uncertainty

    Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.

    Product
    Nerve Block Tray Catalog Number: 6796R3
    Category
    Drug
    Distribution
    Distributed nationwide