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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1376–1400 of 3644

  • HighFDA (Drugs)·D-0407-2024·2024-04-03

    Hydromorphone Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.

    Product
    HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0400-2024·2024-04-03

    Fentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue

    SCA Pharmaceuticals recalls 412 cassettes of fentanyl-bupivacaine epidural injection (lots 1223049261 and 1223049724) due to lack of assurance of sterility.

    Product
    fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0410-2024·2024-04-03

    Hydromorphone Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling 909 syringes of HYDROmorphone HCl 30 mg/30 mL injection nationwide due to lack of assurance of sterility. Patients should not use affected lots and consult their healthcare provider.

    Product
    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0395-2024·2024-04-03

    Fentanyl Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals recalls fentanyl 2,500 mcg/250 mL injection (548 bags) nationwide due to lack of assurance of sterility. The affected product may not meet pharmaceutical sterility standards required for injectable drugs.

    Product
    fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0412-2024·2024-04-03

    Injectable midazolam HCl recalled due to sterility assurance failure

    SCA Pharmaceuticals is recalling Midazolam HCl 100 mg/100 mL injectable nationwide because the manufacturer cannot assure sterility of the product. Users should consult their healthcare provider regarding affected lot numbers.

    Product
    Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0394-2024·2024-04-03

    Diltiazem HCl Injection Lacks Sterility Assurance; SCA Pharmaceuticals Recalls

    SCA Pharmaceuticals is recalling Diltiazem HCl 125 mg Injectable (381 bags) due to lack of sterility assurance. Patients and healthcare providers should not use affected units from lot #1223049625.

    Product
    Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0414-2024·2024-04-03

    Phenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues

    SCA Pharmaceuticals is recalling Phenylephrine HCl injections nationwide affecting approximately 33,000 units due to lack of assurance of sterility.

    Product
    PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0406-2024·2024-04-03

    HYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues

    SCA Pharmaceuticals is recalling 1,425 syringes of HYDROmorphone HCl 6 mg/30 mL due to lack of assurance of product sterility. The affected lots were distributed nationwide.

    Product
    HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0402-2024·2024-04-03

    fentaNYL 1,250 mcg Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling fentaNYL 1,250 mcg/25 mL injection syringes due to lack of sterility assurance. The nationwide recall affects 1,259 syringes; patients should contact their healthcare provider.

    Product
    fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0411-2024·2024-04-03

    Labetalol HCl Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling labetalol HCl injection due to lack of sterility assurance. The recall affects 2,458 syringes distributed nationwide.

    Product
    labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0398-2024·2024-04-03

    FDA Recalls SCA Fentanyl-Bupivacaine Epidural Injection Cassettes Lacking Sterility Assurance

    SCA Pharmaceuticals is recalling 613 cassettes of fentanyl-bupivacaine epidural injection nationwide due to lack of assurance of sterility.

    Product
    fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0425-2024·2024-04-03

    Vancomycin Injectable Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling 368 bags of vancomycin 1.25 g injectable nationwide because the company cannot assure sterility was maintained. The affected lot was distributed across the USA.

    Product
    VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0396-2024·2024-04-03

    Fentanyl Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals recalls fentanyl 2,500 mcg injection due to lack of sterility assurance. Affected batches were distributed nationwide.

    Product
    fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0416-2024·2024-04-03

    PHENYLephrine Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals recalls PHENYLephrine HCl injectable syringes nationwide due to lack of sterility assurance. The recall affects 1,118 syringes across two lot numbers distributed throughout the USA.

    Product
    PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID fo
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0404-2024·2024-04-03

    FDA Recalls HYDROmorphone Injection Cassettes Due to Sterility Concerns

    SCA Pharmaceuticals recalls 256 units of HYDROmorphone HCl injection in Grey CADD Cassettes nationwide due to lack of assured sterility. The affected lot is #1223049529 with expiration date 01/03/24.

    Product
    HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0428-2024·2024-04-03

    Oral Contraceptive Tablets Recalled for Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling TRI-LO-SPRINTEC oral contraceptive tablets nationwide due to failed dissolution specifications affecting 92,676 cartons.

    Product
    TRI-LO-SPRINTEC — TRI-LO-SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1109-2024·2024-04-03

    Nordic Naturals Baby Vitamin D3 Liquid Recalled for Elevated Levels

    Nordic Naturals has recalled its Baby's Vitamin D3 dietary supplement liquid due to elevated vitamin D3 levels. The recall affects approximately 5,564 bottles with lot number 234909.

    Product
    Nordic Naturals Baby s Vitamin D3 liquid, 400 IU (10 mcg) D3, 0.76 fl oz (22.5 mL) DIETARY SUPPLEMENT, dark glass bottle
    Category
    Drug
    Distribution
    28 states
  • HighFDA (Drugs)·D-0422-2024·2024-04-03

    FDA Recalls Sodium Citrate Injectable Solution Due to Sterility Concerns

    SCA Pharmaceuticals recalls Sodium Citrate 4% injectable solution syringes (9,624 units) distributed nationwide due to lack of assurance of sterility.

    Product
    Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0417-2024·2024-04-03

    Injectable Phenylephrine Recall Due to Sterility Assurance Failure

    SCA Pharmaceuticals recalled approximately 8,050 syringes of PHENYLephrine HCl injection nationwide due to lack of assured sterility. Affected lots have expiration dates from November 2023 to June 2024.

    Product
    PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0424-2024·2024-04-03

    Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure

    SCA Pharmaceuticals is recalling 5,079 syringes of Succinylcholine Chloride Injection nationwide due to lack of sterility assurance. Affected lots are #1223049085 and #1223049364.

    Product
    SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0419-2024·2024-04-03

    Pharmaceutical Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling PHENYLephrine HCl 40 mg injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider and not use this product.

    Product
    PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0426-2024·2024-04-03

    Divalproex Sodium 250 mg tablets recalled for failed dissolution specifications

    Amneal Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets 250 mg nationwide due to failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0393-2024·2024-03-27

    FDA Recalls Unapproved Tianeptine Elixir Drug Product Nationwide

    Neptune's Fix Tianeptine Elixir, distributed nationwide by Super Chill Products, is recalled because it contains tianeptine, a substance not approved by the FDA for any medical use in the United States. Consumers should not use this product.

    Product
    Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0390-2024·2024-03-27

    Nicardipine Hydrochloride Injection Recalled for Out-of-Specification Organic Impurities

    Eugia US LLC is recalling Nicardipine Hydrochloride Injection nationwide due to failed impurity specifications. The 335,940 affected vials contain organic impurities exceeding acceptable standards.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0389-2024·2024-03-27

    Digoxin Tablets Recalled Due to Cross Contamination with Mycophenolate Mofetil

    Novitium Pharma LLC recalls Digoxin 125mcg tablets nationwide due to cross contamination with mycophenolate mofetil, a different medication. Patients receiving contaminated tablets could experience unintended drug effects.

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