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FDA MedWatch Alerts

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

February 4, 2019

Audience: Health Professional, Pharmacy. Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.The recall, which began in October 201... Read more

FDA Warns Compounders Not to Use Glutathione from Letco Medical to Compound Sterile Drugs

February 1, 2019

Audience: Compounders. FDA is warning compounders not to use glutathione-L-reduced powder distributed by Letco Medical, Decatur, Alabama, to compound sterile injectable drugs for patients. Based on reported adverse events, the agency has concerns with use of the Letco distributed glutathione to compound injectable drugs due to potential endotoxins.Letco supplied this glutathione powder to about 100 compounders in 30... Read more

FDA Warns Patients and Doctors About Recall of Home-Use Test Strips Used with Device to Monitor Blood Thinner Warfarin, Not Authorized for Sale in U.S.

February 1, 2019

Audience: Consumer, Health Professional. The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Medical product distributor Terrific Care/Medex Supply LLC issued a... Read more

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

January 29, 2019

Audience: Consumers. Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.Infants already susceptible to the adverse effects of ibuprofen may be at a... Read more

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDF-5 Inhibitors in the Product

January 29, 2019

Audience: Consumers. Nature’s Rx is voluntarily recalling quantity lots of Silver Bullet 10x, description of dosage form to the hospital, retail or consumer level. This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose s... Read more

FDA Updates on Angiotensin II Receptor Blocker (ARB) Recalls

January 23, 2019

Audience: Consumer, Health Professional, Pharmacy. Investigation ongoing – This page to be updated as more information is available IMPORTANT: Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled. Manufacturers are recalling medications containing amlodipine in combination with valsartan or losartan, and medications containing hydrochlorothiazide HCTZ in combination with v... Read more

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

January 22, 2019

Audience: Consumer, Health Professional, Pharmacy.. Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.The... Read more

Prinston Pharmaceutical Inc. Issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodiethylamine (NDEA) in the Products

January 18, 2019

Audience: Consumer, Health Professional, Pharmacy. Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.Prinston is only... Read more

Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil

January 8, 2019

Audience: Consumers. Happy Together, Inc. Boynton Beach, FL is voluntarily recalling all lots within expiry of the Rhino 5k capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Rhino 5k products renders them unapproved drugs for which... Read more

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

January 8, 2019

Audience: Health Professional, Pharmacy. Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain... Read more

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

January 5, 2019

Audience: Consumer, Health Professional, Pharmacy. Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted... Read more

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

January 3, 2019

Audience: Consumer, Health Professional, Pharmacy. Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing... Read more

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

December 31, 2018

Audience: Consumer, Health Professional, Pharmacy. Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product.   The impurity detected in the finished drug product is N-nitrosodiethylamine (... Read more

Terrific Care, LLC. / Medex Supply Dist, Inc. Issues Nationwide Recall of CoaguChek Test Strips

December 20, 2018

Audience: Consumers. On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc . The products have been found to inaccurately report high INR test results.Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk... Read more

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

December 20, 2018

Audience: Consumer, Health Professional, Pharmacy. Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that... Read more

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

December 20, 2018

Audience: Health Professional, Infectious Disease, Cardiology, Patient. ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for s... Read more

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

December 17, 2018

Audience: Consumer, Health Professional, Pharmacy. Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.For the population most at risk, those with a severe... Read more

FDA Alerts Consumers Not to Use Two E-Liquids Sold by HelloCig Electronic Technology

December 11, 2018

Audience: Consumer. 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. FDA laboratory analysis confirmed “E-Cialis HelloCig E-Liquid” contains the undeclared drugs sildenafil and tadalafil, and “E-Rimonabant HelloCig E-Liquid” contai... Read more

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

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

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FDA MedWatch Alerts Archive