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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7801–7825 of 17772

  • ModerateFDA (Drugs)·D-1406-2019·2019-06-19

    Synthetopes Recalls Sn-Pyrophosphate Kits Due to Processing Control Issues

    Synthetopes Inc. is recalling Sn-Pyrophosphate Kits because of a lack of processing controls. The recall covers all lots remaining within their expiry dates.

    Product
    Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1341-2019·2019-06-19

    Chiesi Recalls ZYFLO CR Tablets Due to Dissolution Failure

    Chiesi USA is recalling ZYFLO CR (zileuton) extended-release tablets because they failed to meet dissolution specifications. The recall affects 2,118 bottles distributed nationwide.

    Product
    ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1395-2019·2019-06-19

    Pecgen DMX Recalled for Incorrect Pediatric Dosage Labeling

    Novis PR, Inc. is recalling Pecgen DMX cough syrup because a typo on the label provides incorrect dosage instructions for children.

    Product
    PECGEN DMX — PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1400-2019·2019-06-19

    Synthetopes Recalls Sn-DMSA Solution Due to Processing Control Deficiencies

    Synthetopes Inc. is recalling Sn-DMSA solution vials nationwide due to a lack of processing controls. The product is not for direct injection.

    Product
    Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1343-2019·2019-06-19

    B. Braun Recalls Heparin Sodium Bags Due to Low Potency

    B. Braun Medical Inc. is recalling 40,176 bags of Heparin Sodium in Dextrose because testing showed the drug had lower potency than required by USP specifications.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1399-2019·2019-06-19

    Synthetopes Recalls Pentreotide Vials Due to Lack of Processing Controls

    Synthetopes Inc. is recalling Pentreotide (10 uGm) vials nationwide due to a lack of processing controls. All lots remaining within expiry are affected.

    Product
    Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1404-2019·2019-06-19

    Synthetopes Recalls Sn-DTPA Kit Due to Lack of Processing Controls

    Synthetopes Inc is recalling 82 vials of Sn-DTPA Kit 10 mg nationwide due to a lack of processing controls.

    Product
    Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1401-2019·2019-06-19

    Synthetopes Recalls Sn-Mertiatide Kit Due to Processing Control Deficiencies

    Synthetopes Inc is recalling Sn-Mertiatide Kits nationwide due to a lack of processing controls. The recall covers all lots remaining within their expiry date.

    Product
    Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1340-2019·2019-06-19

    Glenmark Recalls Estradiol Vaginal Inserts Due to Defective Plunger

    Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts because the plunger delivery system is not functioning properly.

    Product
    ESTRADIOL VAGINAL INSERTS — ESTRADIOL VAGINAL INSERTS (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1437-2019·2019-06-19

    Geritrex Recalls Senna Syrup Due to Atypical Odor and Taste

    Geritrex, LLC is recalling Senna Syrup bottles due to reports of atypical odor and unpleasant taste.

    Product
    Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1396-2019·2019-06-19

    Bausch & Lomb Recalls Lotemax Ophthalmic Gel for Viscosity Issues

    Bausch & Lomb is recalling Lotemax ophthalmic gel because it failed stability specifications for viscosity. The recall covers 17,083 bottles distributed nationwide.

    Product
    LOTEMAX — LOTEMAX (LOTEPREDNOL ETABONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1321-2019·2019-06-05

    Stiff Boy LLC Recalls The Beast Due to Undeclared Sildenafil

    Stiff Boy LLC is recalling The Beast because FDA analysis found undeclared sildenafil. The product was marketed without an approved NDA or ANDA.

    Product
    The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4 Capsules per packet.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1308-2019·2019-06-05

    Avella Recalls Bevacizumab Prefilled Syringes Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 730 prefilled syringes of Bevacizumab 2.5 mg/0.1 mL due to a lack of assurance of sterility.

    Product
    Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416 N. 19TH AVENUE PHOENIX, AZ 85085, NDC 42852-001-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1311-2019·2019-06-05

    Inopak Recalls AQUACIL Hand Sanitizer Due to Manufacturing Deviations

    Inopak Ltd is recalling specific batches of AQUACIL instant foaming hand sanitizer because they were not produced under current good manufacturing practices.

    Product
    AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1317-2019·2019-06-05

    Inopak Recalls Sani-Guard-SF Foam Hand Sanitizer Due to Manufacturing Deviations

    Inopak Ltd is recalling Sani-Guard-SF Waterless Foam Hand Sanitizer because it was not produced under current good manufacturing practices.

    Product
    Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2019·2019-06-05

    Inopak Recalls Mild Health Care Antibacterial Hand Soap for CGMP Deviations

    Inopak Ltd is recalling Mild Health Care Antibacterial Hand Soap because it was not produced under current good manufacturing practices.

    Product
    Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1313-2019·2019-06-05

    Inopak Recalls Inoderm Antiseptic Hand Soap Due to Manufacturing Deviations

    Inopak Ltd is recalling Inoderm Antiseptic Hand Soap because it was not produced under current good manufacturing practices.

    Product
    INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1314-2019·2019-06-05

    Inopak Recalls INOFOAM Food Handling Wash for CGMP Deviations

    Inopak Ltd is recalling INOFOAM Foaming E-2 Food Handling Wash because it was not produced under current good manufacturing practices.

    Product
    INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1315-2019·2019-06-05

    Inopak Recalls Antibacterial Hand Soap Due to Manufacturing Deviations

    Inopak Ltd is recalling specific batches of Healthcare 2000 antibacterial hand soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with C
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1318-2019·2019-06-05

    Inopak Antibacterial Hand Soap Recalled for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Hand Soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1310-2019·2019-06-05

    Inopak Recalls Antibacterial Foaming Hand Wash for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Foaming Hand Wash because they were not produced under current good manufacturing practices.

    Product
    ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming H
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1312-2019·2019-06-05

    Inopak Recalls Hand Sanitizer Due to Manufacturing Practice Deviations

    Inopak Ltd is recalling DermaGel and SaniTyze hand sanitizers because they were not produced under current good manufacturing practices.

    Product
    Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1319-2019·2019-06-05

    Inopak Recalls Unison Hand Cleaner for Manufacturing Practice Violations

    Inopak Ltd is recalling Unison Hand Care Products due to production not meeting current good manufacturing practices.

    Product
    Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 N
    Category
    Drug
    Distribution
    Distributed nationwide