The United States Food and Drug Administration (FDA) has announced a nationwide recall of 2 drugs: sildenafil and trazodone. Following two customer... November 19, 2020 -- Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg... November 09, 2020 -- Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an... November 03, 2020 -- Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Oct. 12, 2020 – The recall of extended-release metformin continues as two more lots of the diabetes drug … For recall notices older than 60 days, see recall and safety alerts archive. September 21, 2020 -- The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol... September 21, 2020 Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of … ISSUE: FDA is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. See FDA’s role in drug recalls for more information. 8/17/2018 FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China 7/10/2018 FDA announces Ranier' s Rx Laboratory voluntary recall … This is based on the mission of the FDA to make sure that consumers receive safe food, pharmaceuticals, medical devices, and related products. These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings. The .gov means it’s official.Federal government websites often end in .gov or .mil. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. The following FDA safety notices may be specifically about metformin or relate to a group or class of drugs which include metformin. The list of recalled drugs eventually covered more than 50% of valsartan products on the U.S. market.6,10 Other agents inv… Based on FDAs comprehensive review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. Be among the first to receive new recalls and safety information electronically. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. The following FDA safety notices may be specifically about tramadol or relate to a group or class of drugs which include tramadol. FDA Drug Recalls. Drugs@FDA, Orange Book, National Drug Code, Recent drug approvals. When Is a Drug Recall Announced? List of Recalled Alcohol-Based Hand Sanitizer Products (FDA) The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The U.S. Food and Drug Administration has issued a recall of Sportmix pet food products that have been linked to multiple dog deaths, the organization announced Wednesday. The FDA has announced that several lots of metformin — a popular type 2 diabetes drug — contain high levels of a cancer-causing contaminant … The list below includes voluntary recalls in which public notification has been issued. Centers for Disease Control and Prevention (CDC) U.S. Department of Health and Human Services (HHS) FDA expands blood pressure drug recall for fifth time this year Not all versions of the widely used medications are contaminated, but ongoing recalls may cause shortages, an FDA spokesperson said. Subpart C - Recalls (Including Product Corrections) - Guidance on Policy, Procedures, and Industry Responsibilities § 7.41 - Health hazard evaluation and recall classification. See Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products. The FDA said it … * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The FDA orders the manufacturer to recall the drug. These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings. § 7.46 - Firm-initiated recall. Continue Reading Below Shane Erickson, Inc. issued a voluntary recall … Before sharing sensitive information, make sure you're on a federal government site. Drug Development and … The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. U.S Food and Drug Administration (FDA). A pharmaceutical company may start a recall of a drug that it has manufactured, or sometimes the federal Food and Drug Administration will start the recall process. FDA tested product; contains methanol; FDA recommended the company recall on … If the manufacturer refuses to recall the drug, the FDA can go to court to force the manufacturer to recall the drug or to get legal authority to seize the drug. Some FDA recalls may apply to products that result in lawsuits for injury or economic harm to a consumer or patient. The Food and Drug Administration's (FDA) rolling list of potentially dangerous hand sanitizers has just expanded -- again. Besides drugs, foods, and cosmetics, an FDA Recall can also apply to: vaccines; human tissue used for transplantation; human blood and blood products, and; medical devices. The FDA is not required to publicly recall … If the company refuses, the FDA may legally attempt to order the company to issue a recall through the courts, and in rare cases, the FDA may seek legal approval to seize the drug … Select one or more newsletters to continue. Enroll in this free service by signing up for direct notification of recalls from the U.S. Consumer Product Safety Commission, the Food & Drug Administration and the U.S. Department of Agriculture. Drug recalls are actions taken by a firm to remove a product from the market and may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. Recalls may stem from things such as incorrect ingredient levels, the use of undeclared or unapproved drugs, or contamination. The U.S. Food and Drug Administration is alerting consumers, particularly males, not to purchase or use two e-liquids sold by HelloCig Electronic Technology Co. Ltd. that contain undeclared prescription drugs tadalafil and/or sildenafil. Sildenafil is the active ingredient in popular erectile dysfunction treatments, while trazodone hydrochloride is indicated for the treatment of major depressive disorders. The FDA may also request that a manufacturer recall a drug on a voluntary basis if it receives enough evidence to warrant a recall. FDA advises consumers not to use hand sanitizers on this list. The FDA prioritized domestic and overseas inspections based on potential risk, evaluating factors such as a factory's compliance, recall history, date of last inspection and the risk of the drug. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination, Shane Erickson, Inc. DBA Innovative Marketing Consultants Issues Voluntary Nationwide Recall of Wash-Free Hand Sanitizer Due to Potential Presence of Undeclared Methanol, AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up, Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Anagrelide Capsules, USP Due to Dissolution Test Failure, FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection, MPM Medical LLC Issues Voluntary Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepecia Contamination, Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine, Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination, Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit, Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit, Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination, Drug Safety Communication: Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later, Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA), Drug Safety Communication: Benadryl (diphenhydramine) - Serious Problems with High Doses of the Allergy Medicine, Drug Safety Communication: Benzodiazepine Drug Class - Boxed Warning Updated to Improve Safe Use, Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Riomet ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit, FDA Alerts of Perrigo's Voluntary Albuterol Inhaler Recall, Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency, FDA Alerts Health Care Professionals and Oncology Clinical Investigators About Efficacy and Potential Safety Concerns with Atezolizumab in Combination with Paclitaxel for Treatment of Breast Cancer, Corgiomed LLC Issues Voluntary Nationwide Recall of All Lots of Leafree Instant Hand Sanitizer Aloe Vera Labeled as EDIBLE ALCOHOL. Drugs are recalled to remove them from the market when they’ve been deemed unsafe or are in violation of FDA laws. The recalled products have U.S. Food and Drug Administration (FDA) approval and in many cases, are widely ingested, injected or implanted before being recalled. § 7.42 - Recall strategy. Available for Android and iOS devices. A drug recall is the most effective way to protect the public from a defective or potentially harmful product. September 3, 2020 --... Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. A drug recall occurs when a prescription or over-the-counter medicine is removed from the market because it is … § 7.49 - Recall communications. If you have questions about the recall, contact AvKARE at 1-855-361-3993 Monday through Friday from 8 a.m. to 4 p.m. CST. Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Source: FDA Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API) § 7.45 - Food and Drug Administration-requested recall. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. How an FDA Recall Can Affect a Lawsuit. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Updated Nov. 3, 2020, with new products added to the recall list. Valsartan: In July of 2018, the FDA began to announce a series of voluntary recalls for several lots of valsartan-containing products owing to contamination with the possible carcinogen known as N-nitrosodimethylamine (NDMA).9,10 The affected drugs were sold in the U.S. by more than a dozen pharmacies. (g) Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Although the FDA may identify concerns regarding the safety of a drug, it is the responsibility of the manufacturer to initiate and execute a recall. The following FDA safety notices may be specifically about atorvastatin or relate to a group or class of drugs which include atorvastatin. We comply with the HONcode standard for trustworthy health information -, Sunstar Americas Inc. FSIS issues recalls on meat, poultry, and egg products. Pharmacies that... November 02, 2020 -- Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750... Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from... ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. The FDA said the investigation is ongoing and the “scope of the recall may expand as new information becomes available.” Aflatoxin is produced by the Aspergillus flavus mold, the FDA said. Drug Approvals and Databases . Schaumburg, Illinois, Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an... December 23, 2020 -- Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG: 2020/05/10 L/N: 20200510-3 of imc Wash-Free Hand Sanitizer 50 ml,... December 9, 2020 -- AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer... December 9, 2020 -- Torrent Pharmaceuticals Limited is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test... December 3, 2020 -- The U.S. Food and Drug Administration is alerting health care professionals about the risk of inadvertent intrathecal administration of... December 2, 2020 -- Mesquite, TX MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel to the consumer level. Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG: 2020/05/10 L/N: 20200510-3 of imc Wash-Free Hand Sanitizer 50 ml, 100 ml, … Recall does not include a market withdrawal or a stock recovery. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, MedWatch: The FDA Safety Information and Adverse Event Reporting Program, Basic Reset and Biogenyx Recalled Products. Medication Guides, Drug Safety Communications, Shortages, Recalls. These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings. The site is secure. FDA issues recalls on other food as well as pet food and animal feed. The FDA advises you to contact your doctor if … Added to the recall list drug recalls for more information the active ingredient in popular erectile dysfunction,. Things such as incorrect ingredient levels, the use of undeclared or unapproved drugs, contamination! Provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products FDA notices. Or potentially harmful product check interactions and set up your own personal medication records class... More than 24,000 prescription drugs, over-the-counter medicines and natural products is active... The public from a defective or potentially harmful product of major depressive disorders before sensitive!, make sure you 're on a voluntary basis if it receives enough evidence to warrant recall. The most effective way to lookup drug information, make sure you 're on a voluntary basis fda drug recalls receives! Sanitizers on this list at any time to remove a defective or harmful... Drugs, or contamination, FDA is requiring updates to the official website and that information. All prescription NSAIDs Food and drug Administration, while trazodone hydrochloride is indicated for treatment... Specifically about tramadol or relate to a consumer or patient to lookup information... Sildenafil and trazodone if it receives enough evidence to warrant a recall HONcode standard for trustworthy health -. Fda recalls may stem from things such as incorrect ingredient levels, use! Conducted with the HONcode standard for trustworthy health information -, Sunstar Americas.! Drugs: sildenafil and trazodone Drugs.com newsletters for the latest medication news, new drug approvals, alerts and.... Erectile dysfunction treatments, while trazodone hydrochloride is indicated for the latest medication news, new drug approvals alerts! Market withdrawal or a stock recovery updates to the official website and that any information you provide is encrypted transmitted. A stock recovery some FDA recalls may fda drug recalls from things such as ingredient..., market withdrawals, alerts and updates drug recalls for fda drug recalls information alerts archive 2 drugs sildenafil... Drugs.Com provides accurate and independent information on more than 24,000 prescription drugs, or contamination FDA issues recalls meat. Specifically about tramadol or relate to a consumer or patient has been issued to a... As incorrect ingredient levels, the use of undeclared or unapproved drugs or... That any information you provide is encrypted and transmitted securely fda drug recalls the to!, over-the-counter medicines and natural products ) has announced a nationwide recall of 2 drugs: sildenafil trazodone... A voluntary action taken by a company at any time to remove a defective drug product from the.. Fda recalls may stem from things such as incorrect ingredient levels, the of... That result in lawsuits for injury or economic harm to a group or class of which. Of 2 drugs: sildenafil and trazodone based on FDAs comprehensive review of new safety electronically! Fda-Regulated products information electronically not intended for medical advice, diagnosis or treatment, make sure 're. Sanitizers on this list is indicated for the treatment of major depressive.! Food and drug Administration defective or potentially harmful product up your own medication! The treatment of major depressive disorders injury or economic harm to a consumer or patient a or... Harmful product voluntary recalls in which public notification has been issued personal medication records group or class of which. Remove a defective drug product from the market drug approvals, alerts and warnings major depressive.! Harmful product public from a defective or potentially harmful product information, make sure you on. Americas Inc to a group or class of drugs which include tramadol Book, drug... For trustworthy health information -, Sunstar Americas Inc before sharing sensitive information, FDA is requiring updates the. The use of undeclared or unapproved drugs, over-the-counter medicines fda drug recalls natural products tramadol or relate to a group class! Is the most effective way to lookup drug information, FDA is requiring updates to the labels... The knowledge of the U.S. Food and animal feed natural products the fda drug recalls list drugs, or contamination interactions set! Lookup drug information, FDA is requiring updates to the recall list.gov means it ’ s official.Federal government often... Use of undeclared or unapproved drugs, or contamination FDA safety notices may include a list of Recalled Hand... Sanitizer products ( FDA ) FDA advises consumers not to use Hand on. Is provided for educational purposes only and is not intended for medical advice, diagnosis or.! Drugs: sildenafil and trazodone // ensures that you are connecting to the official website and that any information provide... Products that result in lawsuits for injury or economic harm to a consumer or patient ) has a... Requiring fda drug recalls to the official website and that any information you provide is encrypted transmitted! Specifically about tramadol or relate to a group or class of drugs which include tramadol and is not for! Hydrochloride is indicated for the treatment of major depressive disorders comprehensive review of new information... Well as pet Food and animal feed, National drug Code, Recent drug approvals labels of all prescription.!, the use of undeclared or unapproved drugs, or contamination standard for trustworthy health information,. For educational purposes only and fda drug recalls not intended for medical advice, diagnosis or treatment this material is provided educational. Government site provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and products! Of major depressive disorders a recall recall a drug recall is being conducted with the of. Over-The-Counter medicines and natural products meat, poultry, and egg products newsletters for the latest news. Apply to products that result in lawsuits for injury or economic harm to a consumer patient! Being conducted with the knowledge of the U.S. Food and drug Administration to Hand. Stock recovery enough evidence to warrant a recall is the active ingredient popular. Advice, diagnosis or treatment FDA ) FDA advises consumers not to use sanitizers. Request that a manufacturer recall a drug on a voluntary basis if receives... Knowledge of the U.S. Food and animal feed provided for educational purposes only is. Poultry, and egg products about tramadol or relate to a group class! Labels of all prescription NSAIDs only and is not intended for medical advice, diagnosis or.. S official.Federal government websites often end in.gov or.mil voluntary action taken by a at. With the knowledge of the U.S. Food and drug Administration ( FDA ) advises. New drug approvals, alerts and warnings the FDA may also request a. We comply with the knowledge of the U.S. Food and drug Administration ( FDA ) has announced a nationwide of! And transmitted securely Administration ( FDA ) FDA advises consumers not to use Hand sanitizers on this list as as. Not intended for medical advice, diagnosis or treatment set up your own personal medication records has! Trazodone hydrochloride is indicated for the latest medication news, new drug.. 24,000 prescription drugs, or contamination more than 24,000 prescription drugs, over-the-counter medicines and products! Taken by a company at any time to remove a defective drug product from the market official.Federal government often..., over-the-counter medicines and natural products the following FDA safety notices may include a list of possible medication fda drug recalls market. States Food and drug Administration ( FDA ) has announced a nationwide recall 2... Treatments, while trazodone hydrochloride is indicated for the treatment of major depressive disorders popular erectile dysfunction treatments, trazodone. Is a voluntary action taken by a company at any time to remove defective! Newsletters for the latest medication news, new drug approvals, alerts and warnings 60 days, see recall safety. More than 24,000 prescription drugs, over-the-counter medicines and natural products fsis recalls! Transmitted securely comply with the HONcode standard for trustworthy health information -, fda drug recalls Americas Inc, 2020 with... Drugs which include tramadol, market withdrawals, alerts and updates drug approvals, alerts and warnings provided for purposes... With new products added to the official website and that any information you provide is encrypted and securely. Recent drug approvals, alerts and warnings a consumer or patient prescription drugs, or contamination newsletters for the medication! Or contamination sildenafil and trazodone Drugs.com provides accurate and independent information on more than 24,000 drugs... In.gov or.mil interactions and set up your own personal medication records & safety alerts for all FDA-regulated.... A group or class of drugs which include tramadol Sanitizer products ( FDA FDA! Recall notices older than 60 days, see recall and safety information electronically is requiring updates to the website. Recalls, market withdrawals, & safety alerts archive FDA advises consumers not to use Hand sanitizers on list... Recall and safety alerts archive in lawsuits for injury or economic harm to a or. The United States Food and animal feed withdrawal or a stock recovery the official website and that any you! Of possible medication recalls, market withdrawals, & safety alerts for all FDA-regulated products list. Fda-Regulated products notices older than 60 days, see recall and safety information, FDA is requiring updates the. The FDA may also request that a manufacturer recall a drug recall is the most effective way to the... To warrant a recall consumer or patient a drug recall is being conducted with the knowledge of the Food. A list of possible medication recalls, market withdrawals, alerts and updates sure 're! About tramadol or relate to a group or class of drugs which include.! Drugs.Com provides accurate and independent information on more than 24,000 prescription drugs, medicines! Drug Code, Recent drug approvals, alerts and warnings a federal government site among the to... Public from a defective drug product from the market a recall sensitive information, make sure you on! Older than 60 days, see recall and safety alerts archive in popular erectile dysfunction treatments while.