Safety Alerts & Recalls

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Latest Alerts

Generic Manufacturer Recalls Several Drug Products
Actavis Totowa LLC, a generic drug manufacturer, has voluntarily recalled all drug products manufactured at its Little Falls, New Jersey facility. An FDA inspection at Little Falls revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices. This recall includes all OXYCODONE and ACETAMINOPHEN 5/500 mg capsules manufactured by Actavis Totowa, LLC. For more information, please visit: http://www.fda.gov/oc/po/firmrecalls/actavis08_08.html or http://www.actavis.us/RecallFAQ
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FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers
The Food and Drug Administration announced it will require manufacturers of over-the-counter (OTC) pain relievers, fever reducers and cough and cold medications that contain acetaminophen (the active ingredient in Tylenol and many other brands) to revise their labeling to include warnings about potential safety risks, such as liver damage, associated with the use of these popular drugs. For more information, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149573.htm
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Date Published Title Drug Source
2008-08-04 Generic Manufacturer Recalls Several Drug Products Manufacturer
2009-05-01 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-05-04 New FDA Labeling for OTC Pain Relievers Also Applies to Patients Taking Combination Products FDA
2009-05-06 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2010-01-27 Change to Prescribing Information for VELCADE to Include Dosage Adjustment in Liver Impairment Manufacturer
2010-02-03 Voluntary Recall of Additional Lots of Sanofi Pasteur H1N1 Vaccine Manufacturer
2010-02-19 Recall of Four Lots of ANTIBACTERIAL WASHCLOTHS Containing Benzalkonium Chloride FDA
2010-03-16 Novartis Issues Recall Of Single Lot of Amlodipine/Benazepril Capsules at Warehouse/Retail Level FDA
2010-03-31 Schering Recalls Several Lots of Intron A FDA
2010-04-01 Ongoing Recall Of Single Lot of Glyburide and Metformin 2.5 mg/500 mg Tablets FDA
2010-04-08 Recall of Our Family Ibuprofen Caplets 200 mg FDA
2010-06-01 All Lots of Four Select PediaCare Products Recalled Manufacturer
2010-09-11 FDA Sends Warning Letters to Makers of Electronic Cigarettes FDA
2011-05-06 FDA Provides Guidance for Dispensing Devices and Drugmakers Remove OTC Infant Acetaminophen Drops FDA
2011-12-27 Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available FDA
2012-02-19 McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints Manufacturer
2012-02-22 McNeil Consumer Healthcare Announces Recall of Infants’ TYLENOL Oral Suspension, 1 oz. Grape Due to Dosing System Complaints Manufacturer
2012-05-11 FDA Warns on Dangers of Unproven Treatment for Multiple Sclerosis FDA
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