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FDA MedWatch Alerts

FDA Alerts Health Care Professionals and Patients Not to Use Drug Products Intended to be Sterile from Promise Pharmacy

December 7, 2018

Audience: Consumer, Health Professional, Pharmacy. The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that were produced in an inadequately designed processing room and distributed by Promise Pharmacy, Palm Harbor, Florida, due to lack of sterility assurance. Administration of a non-sterile drug product intended to be sterile may... Read more

FDA Updates on Angiotensin II Receptor Blocker (ARB) Recalls

December 6, 2018

Audience: Consumer, Health Professional, Pharmacy. Investigation ongoing – This page to be updated as more information is available Mylan expands its voluntary recall of valsartan-containing productsUpdate [12/6/2018] Mylan Pharmaceuticals is expanding its voluntary recall to include all lots of non-expired valsartan-containing products due to trace amounts of N-Nitrosodiethylamine (NDEA) in the valsartan active p... Read more

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

December 5, 2018

Audience: Consumer, Health Professional, Pharmacy. December 5, 2018 -- Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.There is a remote possibility that infants, who may be more susceptible to a h... Read more

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA Impurity in the Active Pharmaceutical Ingredient

December 4, 2018

Audience: Consumer, Health Professional, Pharmacy. December 4, 2018 -- Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg... Read more

FDA Warns That Symptoms of a Serious Condition Affecting the Blood Cells Are Not Being Recognized with the Leukemia Medicine Idhifa (enasidenib)

November 29, 2018

Audience: Consumer, Health Professional, Pharmacy. The U.S. Food and Drug Administration (FDA) is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa (enasidenib). The Idhifa prescribing information and patient Medication Guide already contain a warning about differentiation... Read more

FDA Warns About Rare But Serious Risks of Stroke and Blood Vessel Wall Tears with Multiple Sclerosis Drug Lemtrada (alemtuzumab)

November 29, 2018

Audience: Consumer, Health Professional, Pharmacy. The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab). These problems can lead to permanent disability and even death. As a result, we have added a new warning about... Read more

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

November 27, 2018

Audience: Consumer, Health Professional, Pharmacy. Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan... Read more

FDA Warns Consumers to Avoid Rhino Male Enhancement Products Found at Retailers Because of Undeclared and Potentially Dangerous Drug Ingredients

November 27, 2018

Audience: Consumers. The U.S. Food and Drug Administration is warning consumers not to purchase or use Rhino male enhancement products, due to a recent rise in reported health issues. Since 2007, the FDA has identified more than 25 products marketed with variations of the name “Rhino” that contained hidden drug ingredient(s). These products continue to be sold at gas stations and convenience stores, as well as on we... Read more

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient

November 20, 2018

Audience: Consumer, Health Professional, Pharmacy. Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP... Read more

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

November 20, 2018

Audience: Consumer, Health Professional, Pharmacy. Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the... Read more

Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine

November 20, 2018

Audience: Patient, Health Professional, Neurology, Pharmacy. ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability. BACKGROUND: Gilenya is one of several medicines approved to treat a form of MS called... Read more

FDA Alerts Health Care Professionals and Patients Not To Use Sterile Drug Products from Pharm D Solutions

November 19, 2018

Audience: Health Care Professionals; Patients. The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions LLC, Houston, Texas, due to lack of sterility assurance. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening... Read more

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

November 14, 2018

Audience: Patient, Caregiver, Health Professional, Pain Management, Pharmacy, Neurology, Surgery. ISSUE: The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump. While individual patients may experience some relief from using pain medicines not approved for... Read more

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

November 8, 2018

Audience: Consumer, Health Professional, Pharmacy. November 8, 2018 -- Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan... Read more

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

November 7, 2018

Audience: Consumer, Health Professional, Pharmacy. Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.Use... Read more

FDA Alerts Patients and Health Care Professionals that Some EpiPen Auto-Injectors May Not Readily Slide Out of Carrier Tube

November 2, 2018

Audience: Consumer, Health Professional, Pharmacy. [11/2/2018] FDA is alerting patients, caregivers and health care professionals that the labels attached to some EpiPen 0.3mg and EpiPen Jr 0.15mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.In a letter to health care professionals from Pfizer, the manufacturer of the... Read more

Janssen Issues Voluntary Nationwide Recall for One Lot of Ortho-Novum 1/35 and Two Lots of Ortho-Novum 7/7/7 Due to Incorrect Veridate Dispenser Instructions

November 2, 2018

Audience: Consumer, Health Professional, Pharmacy. The Ortho-Novum® product itself remains safe and effective for use with the appropriate dispenser instructionsTITUSVILLE, NJ – November 2, 2018 -- Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of Ortho-Novum® 1/35 (norethindrone/ethinyl estradiol) Tablets and two lots of Ortho-Novum® 7/7/7 (norethindrone/ethinyl estradiol) Tablets to the p... Read more

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

October 30, 2018

Audience: Consumer, Health Professional, Pharmacy. October 30, 2018 -- ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma... Read more

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

October 26, 2018

Audience: Consumer, Health Professional, Pharmacy. October 26, 2018 -- Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as... Read more

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

October 22, 2018

Audience: Patients; Prescribers. Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials,to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.To date Promise Pharmacy has not received any reports of adverse events related to this recall. Potential adverse health consequences c... Read more

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