The FDA defines a drug recall as “a voluntary action taken by a company at any time to remove a defective drug product from the market.” Contrary to popular belief, the FDA rarely has to force a manufacturer to recall a drug. We comply with the HONcode standard for trustworthy health information -, Initial Safety Trial Results Find Increased Risk of Serious Heart-Related Problems and Cancer with Xeljanz, Xeljanz XR (tofacitinib), Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection, USP Due to Mislabeling of Syringe Barrel Measurement Markings, Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL Due to Mislabeling, FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers, Nostrum Laboratories, Inc. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. This database contains Medical Device Recalls classified since November 2002. Centers for Disease Control and Prevention (CDC) U.S. Department of Health and Human Services (HHS) These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings. 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. The .gov means it’s official.Federal government websites often end in .gov or .mil. This recall is due to possible undeclared allergens (wheat and tree nuts) in … Before sharing sensitive information, make sure you're on a federal government site. § 7.45 - Food and Drug Administration-requested recall. This is based on the mission of the FDA to make sure that consumers receive safe food, pharmaceuticals, medical devices, and related 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. The FDA orders the manufacturer to recall the drug. 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) A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. The following FDA safety notices may be specifically about amlodipine/atorvastatin or relate to a group or class of drugs which include amlodipine/atorvastatin. The list of recalled drugs eventually covered more than 50% of valsartan products on the U.S. market.6,10 Other agents involved in th… FDA Drug Recalls. * 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). When Is a Drug Recall Announced? When it comes to recalling drugs or other medical products, the stakes are often very high. The Food and Drug Administration will promptly make available to the public in the weekly FDA Enforcement Report a descriptive listing of each new recall according to its classification, whether it was Food and Drug Administration-requested or firm-initiated, and … Subpart C - Recalls (Including Product Corrections) - Guidance on Policy, Procedures, and Industry Responsibilities § 7.40 - Recall policy. § 7.46 - Firm-initiated recall. Annual Patterns of Drug Recalls. Most of the time, manufacturers find out something is wrong with a drug and recall it before consumers are affected, according to Board Vitals. The FDA's initial warning about possible contamination centered on just select batches … NDAL MFG INC is voluntarily recalling one lot of Manukaguard Allercleanse, nasal spray to the consumer level. clear plastic bottles to the consumer... January 4, 2021 -- Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to... December 31, 2020 Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an... December 28, 2020 -- Schaumburg, Illinois, Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12%... 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. 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. See Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products. § 7.42 - Recall strategy. A drug recall occurs when a prescription or over-the-counter medicine is removed from the market because it … 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. Expands 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, FDA Updates Vinca Alkaloid Labeling for Preparation in Intravenous Infusion Bags Only, Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter, Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol, Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination, Sunstar Americas Inc. (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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Make sure your specific medication has been recalled. 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. Source: FDA Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity For recall notices older than 60 days, see recall and safety alerts archive. Dole Fresh Vegetables, Inc. is voluntarily recalling two lot codes of Dole™ Sunflower Crunch Chopped Salad Kit. Recall does not include a market withdrawal or a stock recovery. § 7.41 - Health hazard evaluation and recall classification. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. A drug recall is the most effective way to protect the public from a defective or potentially harmful product. 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. FDA, “FDA Announces Withdrawal Fenfluramine and Dexfenfluramine (Fen-Phen),” www.fda.gov, Sep. 15, 1997 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Updated Nov. 3, 2020, with new products added to the recall list. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. These notices may include a list of possible medication recalls, market withdrawals, alerts and warnings. See FDA’s role in drug recalls for more information. Use of these devices may cause serious injuries or death. Available for Android and iOS devices. By Sholom Nemanow. NDMA is a cancer-causing contaminant called N-Nitrosodimethylamine. Although the FDA cannot currently force a mandatory recall of drugs, it can order a manufacturer to recall a medical device by statute if it finds there is reasonable probability that a device may cause serious injuries or death. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. FDA issues recalls on other food as well as pet food and animal feed. Drug recalls have been steadily increasing since 2014. The Allercleanse nasal sprays have been found to be contaminated with yeast. FSIS issues recalls on meat, poultry, and egg products. The FDA has announced that the common diabetes drug metformin may have unacceptably high levels of a cancer-causing drug. Understanding FDA Drug Recalls Drugs Published May 29, 2020. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. The site is secure. FDA, “FDA Alerts Consumers of Undeclared Drug Ingredients in Over-the-Counter Diabetes Product,” www.fda.gov, July 23, 2013. The Food and Drug Administration said Tuesday it has issued a warning letter to Amazon’s Whole Foods for not labeling some products for … Get informed. Generic valsartan, for example, … Expands 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 January 26, 2021 -- As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent... January 26, 2021 Nostrum Laboratories, Inc. The FDA has identified this as a Class I recall, the most serious type of recall. Select one or more newsletters to continue. The following FDA safety notices may be specifically about celecoxib or relate to a group or class of drugs which include celecoxib. The FDA partial recall applies to only some batches, leaving “undeniably a great proportion of unaffected batches.” Of the dozens of companies that manufacture the drug — which controls blood sugar and has long been the first-line treatment for people with type 2 diabetes — most of them are international. 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... Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. The list below includes voluntary recalls in which public notification has been issued. Many medications are critical to the health of those taking them, and often the specific medication someone takes has no substitution or replacement. February 4, 2021 -- The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased... February 03, 2021 -- Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error... January 27, 2021 -- Meitheal Pharmaceuticals, Inc. (“Meitheal”), announced today that it is voluntarily recalling one (1) lot of Cisatracurium... January 26, 2021 -- As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent... January 25, 2021 -- Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg... January 15, 2021 -- The U.S. Food and Drug Administration is alerting health care professionals to labeling updates for the preparation of vinca alkaloids, a... January 08, 2021 -- Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial... January 4, 2021 -- Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. 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. U.S Food and Drug Administration (FDA).

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