Safety

Recalls, Market Withdrawals, & Safety Alerts

The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.

For recall notices older than 60 days, see the Recall and Safety Alerts Archive.
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Date Brand Name Product Description Reason/ Problem Company Recall Type
09/20/2017 Bristol Farms   Tasty Treats Nonpareils Milk Chocolate   Undeclared Milk First Source 454, 220, 69, 86
09/20/2017 Natures Supplement, Inc.   Dietary Supplement   Unapproved new drug Natures Supplement, Inc. 202, 512, 91, 125
09/20/2017 Rhino 7, Papa Zen, Fifty Shades, and Grand X   Dietary Supplement   Unapproved new drug Gadget Island, Inc. dba Gear Isle 454, 512, 592
09/19/2017 Death Wish Coffee Co.   Nitro Cold Brew Coffee   Potential for Botulin Toxin Death Wish Coffee Co. 454, 220, 69
09/13/2017 Natural Grocers   Organic Deglet Noor Dates Pitted   Undeclared coconut Vitamin Cottage Natural Food Markets, Inc. 454, 220, 69, 76
09/12/2017 Cherry Valley   Cupcakes   Undeclared milk Cherry Valley Marketplace 454, 220, 69, 76
09/11/2017 Medtronic   Infusion sets   A component may be susceptible to being blocked by fluid Medtronic 454, 230
09/10/2017 Frutas Selectas de Tijuana, S. de R.L. of C.V.   Maradol Papayas   Salmonella Bravo Produce Inc. 454, 69
09/10/2017 Frutas Selectas de Tijuana, S. de R.L. of C.V.   Maradol Papayas   Salmonella Bravo Produce Inc. 454, 69, 220
09/09/2017 Coborn’s, Cash Wise   Bread   Undeclared Milk, Soy, and/or Eggs Coborn's, Inc. 454, 69, 76, 220
09/08/2017 San Francisco Foods   Seafood Salad   Undeclared Milk Simply Fresh Foods, Inc. 454, 69, 76
09/07/2017 Garden of Life   Baby Organic Liquid Supplement   Potential Choking Hazard Garden of Life LLC 454, 220, 69
09/06/2017 Genentech   Activase® (alteplase) 100mg vials   Lack of Sterility Assurance of the Sterile Water for Injection Genentech 454, 208
09/05/2017 Wegmans   Muffins   Undeclared walnuts Wegmans 454, 220, 76, 69
09/02/2017 Southeastern Grocers, Publix Supermarkets, Inc. and more   Fajita blend, Stir fry vegetable, Vegetable kabob and more   Listeria monocytogenes Country Fresh Orlando, LLC. 454, 69, 220
09/01/2017 ShopRite   Chocolate Chips   Undeclared milk Wakefern Food Corp. 454, 220, 69, 76
09/01/2017 PharMEDium   Oxytocin   Sub-potency PharMEDium Services, LLC 454, 208
08/31/2017 HYDROmorphone, Levophed   Hydromorphone HCl, Levophed   Lack of Sterility Assurance Hospira, Inc. 454, 208
08/30/2017 Hospira, Inc.   Vancomycin Hydrochloride for Injection   Particulate Matter Hospira, Inc. 454, 208
08/30/2017 Doctor Manzanilla   Allergy, cough medicine   Burkholderia cepacia Mid Valley Pharmaceutical 208
08/30/2017 Piyanping   Anti-Itch Lotion   Contains dexamethasone instead of hydrocortisone Lucky Mart Inc. 208
08/30/2017 Big Win, Uncle Ray's, Gourmet Select, more   Popcorn   Undeclared milk Dedinas Franzak Enterprises 454, 220, 69, 76
08/30/2017 Rajbhog Sweets   Jalebi   Undeclared almonds Rajbhog Distributors GA. Inc. 454, 220, 69, 76
08/28/2017 Big Win   Popcorn   Undeclared milk Dedinas-Franzak Enterprises 454, 220, 69, 76
08/24/2017 Cook Medical   Zenith Alpha™ Thoracic Endovascular Graft ‎products   Products potential for blunt thoracic aortic injury, also known as BTAI or “transection” Cook Medical 454, 230
08/23/2017 Great Value   Frozen organic dark sweet pitted cherry products   Listeria monocytogenes SunOpta Inc’s subsidiary, Sunrise Growers Inc. 454, 220, 69
08/22/2017 Centurion   Ninjacof and Ninjacof A   Potential contamination with Burkholderia cepacia Centurion Labs 454, 208, 220
08/22/2017 OriGen   Catheters   Potential for separation of tube from hub OriGen Biomedical 454, 230
08/18/2017 Bella Pharma   All lots of unexpired sterile drug products   Due to lack of sterility assurance Bella Pharmaceuticals, Inc. 454, 208
08/17/2017 Gazab   Green Raisins   Undeclared Sulfites United Trading Inc. 454, 76
08/17/2017 Atlantic Pharmacy and Compounding   All compounded injectable prescription medications   Due to lack of sterility assurance Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding 454, 208
08/15/2017 Seven Sundays   Vanilla Cherry Pecan Muesli   Undeclared Almonds Seven Sundays, LLC 454, 69, 76, 220, 642
08/14/2017 Dierbergs Kitchen   Flavored Butters   Undeclared Fish, lobster, crab, shrimp, soy and wheat Dierbergs Markets 454, 69, 76, 220
08/14/2017 Amneal Pharmaceuticals LLC   Lorazepam Oral Concentrate, USP 2mg/mL   Misprinted Dosing Droppers Amneal Pharmaceuticals LLC 454, 208
08/12/2017 OPA   Ranch Greek Yogurt Dressing   Undeclared egg Litehouse Inc. 454, 220, 69, 76
08/11/2017 California Aloha Mix   California Aloha Mix   Undeclared almonds, walnuts, and cashews Grand BK Corp. 454
08/11/2017 Madhava   Chocolate Chip Cookie Mix   Undeclared milk Madhava Natural Sweeteners 454
08/10/2017 Leader, Major, Rugby   Liquid drug products   Potential contamination with B. cepacia Cardinal Health 208
08/09/2017 International Laboratories, LLC   Pravastatin Sodium Tablets   Labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets International Laboratories, LLC 91, 208
08/08/2017 The Comfy Cow   Ice Cream   E. coli The Comfy Cow 454, 69
08/08/2017 Schnucks Bakery   Cake   Undeclared pecans Schnucks Bakery 454, 220, 69, 76
08/07/2017 Valery   Papayas   Salmonella Freshtex Produce LLC 454, 69
08/07/2017 Taylor Farms   Coleslaw Kits   Undeclared milk Taylor Farms Retail, Inc. 454, 220, 69, 76
08/04/2017 Cavi   Papayas   Salmonella Agroson’s LLC 454, 69, 220
08/04/2017 Man of Steel   Man of Steel 1 and Man of Steel 2   Contains Undeclared Sildenafil Man of Steel 454, 208
08/02/2017 Amrita   Protein Bars   Listeria monocytogenes Hudson Valley Foods, Inc 454, 69, 91, 220
08/02/2017 Fairway   Blondie cookies   Undeclared Walnuts Fairway ‘‘Like No Other Market’’ ® 454, 69, 76, 220
08/02/2017 Friendly Farms   Key Lime Crunch Tilts   Undeclared Almond Commonwealth Dairy, LLC 454, 69, 76, 220
08/02/2017 Rugby   Diocto Liquid and Diocto Syrup   Potential contamination with Burkholderia cepacia Rugby® Laboratories 454, 208
08/01/2017 AMPT   Dietary Supplement   Unapproved new drug, undeclared milk The AMPT Life, LLC 91, 95, 202, 512
07/28/2017 ICU Medical, Inc.   0.9% Sodium Chloride Injection, USP 1000 mL   Particulate matter ICU Medical, Inc. 91, 208
07/28/2017 liveGfree   Gluten Free Classic Soft White Hamburger Buns   Undeclared Egg Vibrant Health Products 454, 69, 220, 76
07/27/2017 Apace Packaging LLC   Cyclobenzaprine HCl Tablet and Amantadine HCl Capsule   Cyclobenzaprine HCL may contain Amantadine HCL Capsules Apace Packaging LLC 454, 208
07/26/2017 Caribeña   Papaya Maradol   Salmonella Grande Produce 454, 69
07/26/2017 Caribeña   Papaya Maradol   Salmonella Grande Produce 454, 69
07/25/2017 Cantrell Drug Company   All unexpired sterile drug syringes and IV bags   Lack of sterility assurance Cantrell Drug Company 208
07/25/2017 HyVee   Various Pepperoni Refrigerated Pizzas   Undeclared Soy HyVee, Inc. 454, 220, 69, 76
07/24/2017 LaBri's Body Health   Dietary Supplement   Unapproved new drug EZ Weight Loss TX 454, 512, 592

The list above provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products.

  • FDA works with industry and our state partners to publish press releases and other public notices about recalls that may potentially present a significant or serious risk to the consumer or user of the product. Not all recalls have press releases or are posted on this page.
  • The posting of information on this page is separate from FDA's recall classification process. The weekly Enforcement Report lists all recalls after they have been classified by FDA.  For more information about FDA’s product recall authority, process and classification guidelines, see FDA 101: Product Recalls.

Press releases issued more than 60 days ago are accessible in the Recall and Safety Alerts Archive. For more safety information in a specific product area, please visit the links below.

  • Drugs: Additional safety information about human medical products can be found on FDA’s MedWatch page.
  • Animal Health: Additional safety information about products affecting animal health can be found on FDA’s Animal & Veterinary Recalls & Withdrawals page.
  • Biologics: A more complete listing of Biologic Recalls and Market Withdrawal information about can be found on FDA's Biologics Recalls page.
  • Medical Devices: A more complete listing of Medical Device Recalls can be found on FDA’s Medical Device Recalls page.
  • Cosmetics: Additional safety information about cosmetic products can be found at FDA's Cosmetics Recalls and Alert page.

Recalls of raw (fresh and fresh frozen) oysters, clams, mussels, and whole and roe-on scallops See Disclaimer page regarding links to external sites
The safety of these products is ensured by the Interstate Shellfish Sanitation Conference (ISSC), which consists of federal, state, and industry partners who administer the National Shellfish Sanitation Program (NSSP).

Page Last Updated: 09/21/2017
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