Safety Alerts & Recalls

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Latest Alerts

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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Endo Pharmaceuticals Recalls Single Lot of Percocet 10 mg/325 mg
Endo Pharmaceuticals has recalled a single lot of Percocet (oxycodone and acetaminophen tablets, USP) 10 mg/325 mg. Lot number 402243NV is being recalled because a different tablet with the same active ingredients (Endocet 10/325 mg) was found in a bottle from this lot. Percocet contains the active ingredients oxycodone and acetaminophen and is commonly used in the treatment of pain. Oxycodone and acetaminophen is also sold under the brand name Endocet, Oxycet, and Roxicet. This recall alert only applies to the single lot of Percocet (oxycodone and acetaminophen tablets, USP) 10 mg/325 mg. No other oxycodone and acetaminophen products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm258394.htm
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Date Published Title Drug Source
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Acetaminophen with Oxycodone FDA
2011-06-14 Endo Pharmaceuticals Recalls Single Lot of Percocet 10 mg/325 mg Acetaminophen with Oxycodone FDA
2011-06-27 Endo Pharmaceuticals Recalls Endocet Bottles With Wrong Pill Sizes Acetaminophen with Oxycodone Manufacturer
2012-01-09 Possible Supply Shortage and Rare Tablet Mix-up For Opioid Pain Medications from Endo Pharmaceuticals Acetaminophen with Oxycodone FDA
2012-07-22 Endo Pharmaceuticals Recalls One Lot of Endocet Tablets, 10 mg/650 mg Acetaminophen with Oxycodone FDA
2014-05-01 FDA Issues Reminder Warning for Combination Medicines Containing Acetaminophen Acetaminophen with Oxycodone FDA
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Acetaminophen with Pseudoephedrine Manufacturer
2011-01-18 McNeil Consumer Healthcare Initiates Voluntary Recall of Certain Over-The-Counter (OTC) Products Acetaminophen with Pseudoephedrine Manufacturer
2011-03-31 McNeil Recalls 10 Lots of OTC Products, Including Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol Sinus, Benadryl and Sudafed PE Products Acetaminophen with Pseudoephedrine Manufacturer
2010-06-07 Recall of Several Lots of Acetasol HC and Hydrocortisone and Acetic Acid Ear Products FDA
2012-07-25 Qualitest Recalls Several Lots of Hydrocortisone and Acetic Acid Otic Solution FDA
2014-02-20 Ben Venue Laboratories, Inc. Recalls Single Lot of Acetylcysteine Solution 10%, 30 mL Vial Acetylcysteine FDA
2010-06-11 UCB Manufacturing, Inc and DSM Pharmaceuticals, Inc Recall Two Lots of Semprex-D Capsules Acrivastine and Pseudoephedrine FDA
2007-10-01 Early communication of ongoing safety review Actonel Plus Calcium FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Actonel Plus Calcium FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Actonel Plus Calcium FDA
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2008-09-18 FDA Stops Imports of Ranbaxy Products Acyclovir FDA
2008-06-04 Early communication regarding cancer link in children Adalimumab FDA
2008-09-04 TNF Blockers Increase the Risk of Fungal Infections Adalimumab FDA
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