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 the agency’s own highest classification or reported deaths or serious injuries, 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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10401–10425 of 17987

  • SevereFDA (Drugs)·D-1167-2017·2017-09-27

    Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns

    Pfizer is recalling 115,370 vials of Hydromorphone Hydrochloride Injection because a damaged sterilizing filter may have compromised sterility assurance during manufacturing.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1175-2017·2017-09-27

    Genentech Recalls Activase Due to Cracked Sterile Water Vials

    Genentech is recalling 16,882 units of Activase (alteplase) because the included sterile water vials may have cracked or chipped glass.

    Product
    Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1174-2017·2017-09-27

    Medisca Recalls Aminocaproic Acid API Due to CGMP Labeling Deviations

    Medisca, Inc. is recalling Aminocaproic Acid API lots because the product was manufactured for industrial use but labeled for pharmacy compounding.

    Product
    Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only, Packed by Medisca Inc., Plattsburgh, NY 12901, CAS: 60-32-1.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1166-2017·2017-09-27

    PharMEDium Recalls Fentanyl Citrate Due to Expired Diluent

    PharMEDium Services is recalling 295 bags of compounded Fentanyl Citrate because the diluent used was expired before the product's assigned expiration date.

    Product
    Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1165-2017·2017-09-27

    PharMEDium Recalls Fentanyl Citrate Bags Due to Expired Diluent

    PharMEDium Services is recalling 590 bags of compounded Fentanyl Citrate because the diluent used was expired before the product's assigned expiration date.

    Product
    Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1169-2017·2017-09-27

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 321,900 Daytrana patches because the delivery system no longer meets release liner removal specifications.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1163-2017·2017-09-27

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failures

    Pfizer is recalling 14,712 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.

    Product
    Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1164-2017·2017-09-27

    Pfizer Recalls Quillivant XR Methylphenidate Suspension Due to Dissolution Failure

    Pfizer is recalling 11,790 bottles of Quillivant XR methylphenidate extended-release oral suspension because the product failed dissolution specifications.

    Product
    Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1144-2017·2017-09-20

    FDA Recalls New Kopi Jantan Coffee for Undeclared Ingredients

    Bestherbs Coffee LLC is recalling New Kopi Jantan coffee packets because they contain undeclared desmethyl carbodenafil and milk.

    Product
    New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and each box contains 25 packets, Made in Malaysia, USA Distributor: Bestherbscoffee LLC (USA), Email: [email protected]
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1145-2017·2017-09-20

    Super Panther 7K Capsules Recalled for Unapproved Ingredients

    Chiavna Saffron LLC is recalling Super Panther 7K Capsules because FDA analysis found the product was tainted with sildendafil and tadalafil and marketed without an approved NDA/ANDA.

    Product
    Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1156-2017·2017-09-20

    Bella Pharmaceuticals Recalls Lidocaine Ophthalmic Gel Due to Sterility Concerns

    Bella Pharmaceuticals is recalling Lidocaine Ophthalmic Gel 3.5% because the product lacks assurance of sterility.

    Product
    Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1147-2017·2017-09-20

    Bella Pharmaceuticals Recalls Methylcobalamin Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling Methylcobalamin 10mg vials because the company cannot ensure the product is sterile.

    Product
    Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1149-2017·2017-09-20

    Bella Pharmaceuticals Recalls G.A.C Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling G.A.C 25/100/250mg vials because the company cannot ensure the product is sterile.

    Product
    G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1159-2017·2017-09-20

    Bella Pharmaceuticals Recalls Fluorescein Sodium Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 644 vials of Fluorescein Sodium due to a lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1155-2017·2017-09-20

    Bella Pharmaceuticals Recalls MIC 25/50/50 Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling MIC 25/50/50 vials because the company cannot ensure the product is sterile. The recall affects 5 vials distributed nationwide.

    Product
    MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1146-2017·2017-09-20

    Bella Pharmaceuticals Recalls PF-Glutathione Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 82 vials of PF-Glutathione 200mg/ml because the product lacks assurance of sterility.

    Product
    PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2017·2017-09-20

    Bella Pharmaceuticals Recalls Sodium Bicarbonate Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling specific lots of Sodium Bicarbonate 8.4% vials because the company cannot ensure the product is sterile.

    Product
    Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1143-2017·2017-09-20

    Andropharm M1 Alpha capsules recalled for lack of FDA approval

    Andropharm, LLC is recalling 1,250 bottles of M1 Alpha capsules sold in Florida because the product was marketed without an approved NDA or ANDA.

    Product
    ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1161-2017·2017-09-20

    Bella Pharmaceuticals Recalls BevaDex Syringes Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 200 prefilled BevaDex syringes nationwide because the company cannot guarantee the product's sterility.

    Product
    BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide