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Drug Recalls, Alerts, and Warnings

FDA Recalls, Alerts, and Warnings

Welcome to the FDA Recalls, Alerts, and Warnings page. Here you will find an up-to-date list of drugs for which the Food and Drug Administration (FDA) has issued a recall, alert, or warning. To read the accompanying FDA press release on any drug listed below, simply click on the title of the release.

This page was last updated on Aug 1, 2008
Date Generic Name Trade Name Details
July 30, 2008 serrano peppers from Mexico n/a
July 30, 2008 unapproved drug products Various
July 28, 2008 American Lobster (Maine Lobster) Tomalley n/a
July 25, 2008 Jalapeņo and Serrano Peppers n/a
July 24, 2008 dietary supplement Xiadafil VIP
July 17, 2008 cochlear implant HiRes90k Implantable Cochlear Stimulator
July 17, 2008 tomatoes various
July 8, 2008 fluoroquinolone antimicrobial drugs various
June 19, 2008 animal food products various
June 17, 2008 fake cancer cures n/a
June 16, 2008 antipsychotic drugs n/a
June 8, 2008 raw red plum, red Roma or round red tomatoes n/a
June 6, 2008 becaplermin Regranex
June 6, 2008 bpa Bisphenol-A
June 3, 2008 raw red plum, red Roma or round red tomatoes n/a
May 30, 2008 hydrofluoroalkane (HFA)-propelled albuterol inhalers n/a
May 27, 2008 n/a Xiadafil VIP Tabs
May 23, 2008 nipple cream Mommy's Bliss
May 16, 2008 dried smoked catfish, smoked seafood n/a
May 16, 2008 prescription cough and cold products various
May 15, 2008 cream cheese and seafood Various
May 14, 2008 n/a Trasylol
May 1, 2008 n/a Total Body Formula, Total Body Mega Formula
April 30, 2008 n/a LIFEPAK
April 24, 2008 pet food Various
April 24, 2008 cattle materials NA
April 12, 2008 puffed rice, puffed wheat Various
April 9, 2008 n/a Total Body Formula, Total Body Mega Formula
March 27, 2008 requirements for safety plans for certain drugs and biologics n/a
March 27, 2008 n/a Total Body Formula, Total Body Mega Formula
March 26, 2008 coronary drug-eluting stents Various
March 25, 2008 n/a Blue Steel, Hero
March 22, 2008 cantaloupes Agropecuaria Montelibano cantaloupes
March 11, 2008 not available Tussionex Pennkinetic Extended-Release Suspension
March 6, 2008 Various Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus
February 11, 2008 heparin sodium Baxter's Multiple-dose Vial Heparin
February 8, 2008 botulinum toxin Type A; botulinum toxin Type B Botox, Botox Cosmetic
February 7, 2008 canned vegetables Various
February 6, 2008 colchicine Various
February 5, 2008 ciguatera fish poisoning Various
February 1, 2008 varenicline Chantix
January 31, 2008 antiepileptic Various
January 25, 2008 heparin and saline pre-filled flush syringes Sierra Pre-filled, Inc.; B. Braun
January 25, 2008 ezetimibe and simvastatin Vytorin
January 18, 2008 Canned green beans, canned garbanzo beans Various
January 17, 2008 over-the-counter cough and cold products None available
January 9, 2008 Bio-identical hormone replacement therapy (BHRT) drugs none available
January 3, 2008 erythropoiesis-stimulating agents (ESAs) Aranesp, Epogen, Procrit

NOTE: Click on the Details to read the details of the recall.

Date:July 30, 2008
Generic Name:serrano peppers from Mexico
Trade Name:n/a
Manufacturer :various
Type of Drug/Product:Raw serrano peppers and raw jalapeņo peppers from Mexico.
FDA Release:The FDA has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Tamaulipas, Mexico contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. The FDA is advising consumers to avoid raw serrano peppers and raw jalapeņo peppers from Mexico, and any foods that contain them. The FDA is still analyzing many of the samples taken at various farms in Mexico. If laboratory results warrant, the FDA will provide consumers with additional cautions or warnings necessary to protect their health.

Date:July 30, 2008
Generic Name:unapproved drug products
Trade Name:Various
Manufacturer :KV Pharmaceutical Co., St. Louis, MO
Type of Drug/Product:Treatments for cough, cold, topical wound healing, skin bleaching, gastrointestinal conditions and narcotic drug products.
FDA Release:The FDA and the U.S. Marshals Service seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company. The seizure followed an inspection of several of the company's plants, where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing several unapproved new drug products. The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.
Date:July 28, 2008
Generic Name:American Lobster (Maine Lobster) Tomalley
Trade Name:n/a
Manufacturer :n/a
Type of Drug/Product:Soft, green substance in the lobster body cavity
FDA Release:The FDA warned consumers to avoid eating tomalley in American Lobster (Maine Lobster) because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). The FDA advisory applies only to tomalley, the soft, green substance found in the body cavity of the lobster that functions as the liver and pancreas. Studies have shown that even when high levels of PSP toxins are present in lobster tomalley, lobster meat itself is typically unaffected. Symptoms of PSP include tingling and/or numbness of the mouth, face or neck; muscle weakness; headache; and nausea. In extreme cases, when large amounts of the toxin are consumed, these symptoms can lead to respiratory failure and death.
Date:July 25, 2008
Generic Name:Jalapeņo and Serrano Peppers
Trade Name:n/a
Manufacturer :various
Type of Drug/Product:U.S. Grown Jalapeņo and Serrano Peppers
FDA Release:The FDA is advising consumers that jalapeņo and Serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. In addition, commercially canned, pickled and cooked jalapeņo peppers from any and all geographic locations also are not connected with the outbreak. However, the FDA continues to advise consumers to avoid raw jalapeņo peppers - and the food that contains them - if they have been grown, harvested or packed in Mexico.
Date:July 24, 2008
Generic Name:dietary supplement
Trade Name:Xiadafil VIP
Manufacturer :SEI Pharmaceuticals, Inc., Miami, FL
Type of Drug/Product:Erectile dysfunction treatment
FDA Release:U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets at the request of the FDA. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, the lots seized represent an illegally marketed drug containing an undeclared ingredient. The FDA had formally requested that SEI Pharmaceuticals recall specific lots of Xiadafil VIP tablets. The company, however, refused, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.
Date:July 17, 2008
Generic Name:cochlear implant
Trade Name:HiRes90k Implantable Cochlear Stimulator
Manufacturer :Advanced Bionics, LLC, Sylmar, CA
Type of Drug/Product:treatment for hearing loss
FDA Release:The FDA has reached a settlement with hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. The alleged violations involved the failure to notify the FDA of a change of outside supplier or vendor, which may have exposed patients to unnecessary health risks, such as device failure and surgery. The FDA considered those devices - shipped to health care providers across the country after the company changed suppliers - to be adulterated, as they were no longer covered by the agency's original product approval, granted in 2003.
Date:July 17, 2008
Generic Name:tomatoes
Trade Name:various
Manufacturer :n/a
Type of Drug/Product:Vegetable
FDA Release:The FDA is updating its warning to consumers nationwide concerning the outbreak of Salmonella Saintpaul. After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. The FDA, working with officials from the Centers for Disease Control and Prevention and state and local health departments, is continuing to follow epidemiological and other evidence showing that raw jalapeņo and raw serrano peppers now available in the domestic market may be linked to illnesses in this outbreak.
Date:July 8, 2008
Generic Name:fluoroquinolone antimicrobial drugs
Trade Name:various
Manufacturer :various
Type of Drug/Product:treatment/prevention of certain bacterial infections
FDA Release:The FDA has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendonitis and tendon rupture is necessary. The agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects. The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin and generic ofloxacin.
Date:June 19, 2008
Generic Name:animal food products
Trade Name:various
Manufacturer :various
Type of Drug/Product:Animal food housed and distributed by PETCO
FDA Release:At the request of the FDA, various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., were seized. The seized products violate the Federal Food, Drug, and Cosmetic Act because it was alleged in a case filed by the United States Attorney that they were being held under unsanitary conditions. During an FDA inspection of a PETCO distribution center in April, widespread and active rodent and bird infestation was found. The FDA inspected the facility again in May and found continuing and widespread infestation.
Date:June 17, 2008
Generic Name:fake cancer cures
Trade Name:n/a
Manufacturer :various
Type of Drug/Product:Fake cancer cure and prevention
FDA Release:The FDA has sent Warning Letters to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves and creams, and are sold under various names on the Internet. The FDA urges consumers to consult their health care provider about discontinuing use of these products and to seek appropriate medical attention if they have experienced any adverse effects.
Date:June 16, 2008
Generic Name:antipsychotic drugs
Trade Name:n/a
Manufacturer :various
Type of Drug/Product:Conventional antipsychotic drugs
FDA Release:The FDA exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. The Boxed Warning for both classes of drugs will say that clinical studies indicate antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.
Date:June 8, 2008
Generic Name:raw red plum, red Roma or round red tomatoes
Trade Name:n/a
Manufacturer :various
Type of Drug/Product:Raw red tomatoes
FDA Release:The FDA is alerting consumers nationwide not to eat specific types of raw tomatoes unless the tomatoes are grown and harvested from states, territories and countries that have not been associated with this outbreak. The list of unaffected areas includes: Arkansas, California, Georgia, Hawaii, North Carolina, South Carolina, Tennessee, Texas, Belgium, Canada, Dominican Republic, Guatemala, Israel, Netherlands and Puerto Rico. A salmonellosis outbreak appears to be linked to consumption of raw red plum, red Roma or round red tomatoes and products containing these raw red tomatoes.
Date:June 6, 2008
Generic Name:becaplermin
Trade Name:Regranex
Manufacturer :Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ
Type of Drug/Product:Treatment for leg and foot ulcers
FDA Release:The FDA announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use three or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label.
Date:June 6, 2008
Generic Name:bpa
Trade Name:Bisphenol-A
Manufacturer :Various
Type of Drug/Product:Agent in plastics
FDA Release:A subcommittee of the FDA's Science Board will hold a public meeting on the safety of bisphenol-A (BPA) in plastics, review an Agency Task Force report on the topic, and deliver its findings to the Board's annual meeting this fall. The FDA has been reviewing emerging literature on BPA on a continuous basis for years, and it's Center for Food Safety and Applied Nutrition initiated a formal reexamination of the safety of BPA in early 2007. In April 2008, the National Toxicology Program (NTP) of the National Institutes of Health published a Draft Brief indicating that some studies in animals suggest that BPA may raise concerns for developmental effects in humans.
Date:June 3, 2008
Generic Name:raw red plum, red Roma or round red tomatoes
Trade Name:n/a
Manufacturer :various
Type of Drug/Product:Raw red tomatoes
FDA Release:The FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. The specific type and source of tomatoes are under investigation. However, preliminary data suggest that raw red plum, red Roma or round red tomatoes are the cause. At this time, consumers in New Mexico and Texas should limit their tomato consumption to tomatoes that have not been implicated in the outbreak. These include cherry tomatoes, grape tomatoes, tomatoes sold with the vine still attached and tomatoes grown at home.
Date:May 30, 2008
Generic Name:hydrofluoroalkane (HFA)-propelled albuterol inhalers
Trade Name:n/a
Manufacturer :various
Type of Drug/Product:Bronchospasm treatment
FDA Release:The FDA issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008. CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.
Date:May 27, 2008
Generic Name:n/a
Trade Name:Xiadafil VIP Tabs
Manufacturer :SEI Pharmaceuticals, Miami, FL
Type of Drug/Product:Dietary supplement/ED treatment
FDA Release:The FDA requested that SEI Pharmaceuticals recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction (ED).
Date:May 23, 2008
Generic Name:nipple cream
Trade Name:Mommy's Bliss
Manufacturer :MOM Enterprises, Inc., San Rafael, CA
Type of Drug/Product:Treatment to heal dry or cracked nipples
FDA Release:The FDA is warning consumers not to use or purchase Mommy's Bliss Nipple Cream because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The potentially harmful ingredients are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.
Date:May 16, 2008
Generic Name:dried smoked catfish, smoked seafood
Trade Name:n/a
Manufacturer :Hope Food Supply Inc., Pasadena, TX
Type of Drug/Product:Smoked seafood products
FDA Release:The FDA directed Hope Food Supply Inc., to shut down and immediately recall all products manufactured from its Texas facility since 2007. The company, under a different name, had manufactured dried smoked catfish steaks and other smoked seafood products and had been subject to a consent decree of permanent injunction requiring it to develop and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its fish and fishery products. The firm had not developed this plan. The company cannot restart manufacturing until they have implemented an FDA-approved HACCP plan.
Date:May 16, 2008
Generic Name:prescription cough and cold products
Trade Name:various
Manufacturer :Scientific Laboratories Inc., Lanham, MD
Type of Drug/Product:Prescription cough and cold products
FDA Release:The FDA announced that Scientific Laboratories Inc. is barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products including: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products.
Date:May 15, 2008
Generic Name:cream cheese and seafood
Trade Name:Various
Manufacturer :Lifeway Foods, Inc., Morton Grove, IL
Type of Drug/Product:Cream cheese and seafood products
FDA Release:The FDA announced the shutdown of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., until they are found compliant with food-safety laws. A consent decree of permanent injunction, signed by both corporations and two of their top executives, Julie and Edward Smolyansky (the defendants), halts cream cheese and seafood processing in facilities in Skokie, Ill., and Philadelphia, Pa. The FDA's enforcement action follows the defendants' extensive history of violations of the Federal Food, Drug, and Cosmetic Act dating back to at least 2004.
Date:May 14, 2008
Generic Name:n/a
Trade Name:Trasylol
Manufacturer :Bayer HealthCare Pharmaceuticals Corp., Leverkusen, Germany
Type of Drug/Product:Bleeding control during heart surgery
FDA Release:Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician's stock. The FDA will work with Bayer to ensure a smooth and complete process. Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol.
Date:May 1, 2008
Generic Name:n/a
Trade Name:Total Body Formula, Total Body Mega Formula
Manufacturer :Total Body Essential Nutrition, Inc., Atlanta, GA
Type of Drug/Product:Dietary supplement
FDA Release:The FDA announced that its final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium. On April 9, 2008, the FDA reported the dietary supplement products contained hazardous amounts of selenium in samples of "Total Body Formula" in Tropical Orange and Peach Nectar flavors and "Total Body Mega Formula" in the Orange/Tangerine flavor. Further FDA analysis of the products found high levels of chromium as well. Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake also can interfere with certain medications.
Date:April 30, 2008
Generic Name:n/a
Trade Name:LIFEPAK
Manufacturer :Physio-Control, Inc., Redmond, WA; Medtronic, Inc., Minneapolis, MN
Type of Drug/Product:Heart Defibrillator
FDA Release:The FDA announced that device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. The consent decree prohibits the manufacture, distribution and export of specified AEDs at or from Physio-Control's facility in Redmond, Wash., until the devices and facilities have been shown to be in compliance with the Food and Drug Administration's (FDA) current Good Manufacturing Practice (cGMP) requirements, as set forth in the Quality System regulation for devices. The AEDs subject to the decree include: LIFEPAK 12, LIFEPAK 20, LIFEPAK 500, LIFEPAK 1000, LIFEPAK CR PLUS, LIFEPAK EXPRESS; and their components and accessories, including the LIFENET Systems.
Date:April 24, 2008
Generic Name:pet food
Trade Name:Various
Manufacturer :Evanger's Dog & Cat Food Co., Inc., Wheeling, IL
Type of Drug/Product:Low-acid canned food products
FDA Release:The FDA issued an order requiring that Evanger's Dog & Cat Food Co., Inc. obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce. A recent inspection revealed significant deviations from prescribed documentation of processes, equipment and recordkeeping in the production of the company's thermally processed low-acid canned food (LACF) products. These problems could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.
Date:April 24, 2008
Generic Name:cattle materials
Trade Name:NA
Manufacturer :Various
Type of Drug/Product:Parts of cattle used in animal feed
FDA Release:The FDA issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease"). The new measure builds on FDA's 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed. The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE.
Date:April 12, 2008
Generic Name:puffed rice, puffed wheat
Trade Name:Various
Manufacturer :Malt-O-Meal Company; Minneapolis, MN
Type of Drug/Product:Cereal
FDA Release:The FDA ann