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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5551–5575 of 17772

  • SevereFDA (Drugs)·D-0222-2021·2021-01-20

    Paroex Oral Rinse Recalled for Potential Bacterial Contamination

    Sunstar Americas is recalling Paroex Oral Rinse due to potential Burkholderia cepacia complex contamination and manufacturing facility violations.

    Product
    Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2021·2021-01-20

    Edge Pharma Recalls Methotrexate Syringes Due to Sterility Testing Concerns

    Edge Pharma, LLC is recalling 71 syringes of Methotrexate USP Sterile Solution for Injection because the media used for post-compounding sterility testing was expired.

    Product
    Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0230-2021·2021-01-20

    Zapien Hand Sanitizer Recalled for Sub-Potent Product

    GAZA is recalling Zapien Hand Sanitizer Gel due to cGMP deviations and sub-potent product from the same facility.

    Product
    Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0228-2021·2021-01-20

    Precision Dose Recalls Chlorhexidine Gluconate Oral Rinse Due to cGMP Deviations

    Precision Dose Inc. is recalling Chlorhexidine Gluconate Oral Rinse USP 0.12% unit dose cups due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0221-2021·2021-01-20

    Akorn Recalls Levetiracetam Oral Solution Due to Leaking Bottles

    Akorn, Inc. is recalling specific lots of Levetiracetam Oral Solution because customer complaints reported the liquid leaking from the bottles.

    Product
    Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0229-2021·2021-01-20

    Pristine Hand Sanitizer Recalled for Sub-Potent Product at Facility

    GAZA Proveedora de Servicios de Hospedaje y Alimentos is recalling Pristine Hand Sanitizer Gel due to cGMP deviations and sub-potent product at the manufacturing facility.

    Product
    Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5,
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0223-2021·2021-01-20

    US Compounding Recalls Succinylcholine Chloride Injection Due to Labeling Error

    US Compounding Inc is recalling 1,534 syringes of Succinylcholine Chloride Injection because the lot number and expiration date were printed in the wrong position, making them illegible.

    Product
    Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0224-2021·2021-01-20

    KVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity

    KVK-Tech, Inc. is recalling 528 bottles of Benzhydrocodone and Acetaminophen Tablets because the N-Oxide impurity exceeded specifications during stability testing.

    Product
    Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0194-2021·2021-01-13

    SCA Pharmaceuticals Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,614 syringes of Glycopyrrolate 1 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0214-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0192-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 996 fentanyl and bupivacaine syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0198-2021·2021-01-13

    SCA Pharmaceuticals Recalls Labetalol HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 9,057 syringes of labetalol HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0204-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 23,029 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0190-2021·2021-01-13

    SCA Pharmaceuticals Recalls Esmolol Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 952 syringes of Esmolol HCl 100 mg/10 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0195-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,092 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0197-2021·2021-01-13

    SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 11,075 syringes of Ketamine 100 mg/10mL injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2021·2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 116 Morphine Sulfate syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0211-2021·2021-01-13

    SCA Pharmaceuticals Recalls Rocuronium Br Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 13,096 syringes of Rocuronium Br 50 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0205-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,890 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2021·2021-01-13

    SCA Pharmaceuticals Recalls Sodium Citrate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% Anticoagulation Solution due to a lack of assurance of sterility and potential defective caps.

    Product
    Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0176-2021·2021-01-13

    Merck Recalls Zerbaxa Injection Vials Due to Sterility Test Failures

    Merck Sharp & Dohme is recalling 106,503 vials of Zerbaxa (ceftolozane and tazobactam) injection because sterility tests on related batches failed.

    Product
    ZERBAXA — ZERBAXA (CEFTOLOZANE AND TAZOBACTAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0212-2021·2021-01-13

    SCA Pharmaceuticals Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 5,067 syringes of Succinylcholine Chloride 100 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0215-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 428 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022
    Category
    Drug
    Distribution
    Distributed nationwide