Safety Alerts & Recalls

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McNeil Recalls Single Lot of Tylenol Extra Strength Caplets, 225 count
McNeil Consumer Healthcare is recalling one lot of Tylenol, Extra Strength Caplets, 225 count bottles, distributed in the U.S. This recall is being issued because of a small number complaints of musty, moldy odor. The uncharacteristic musty, moldy smell has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA). This voluntary action is being taken as a precaution and the risk of serious adverse medical events is very rare. TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms including nausea, stomach pain, vomiting, or diarrhea. The recall is for Tylenol Extra Strength Caplets, 225 count, lot number ABA619. The lot number can be found on the side of the bottle label. Tylenol contains the active ingredient acetaminophen. No other acetaminophen products were involved in this recall. For more information, please visit: http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_6.inc
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Qualitest Recalls Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets
Qualitest Pharmaceuticals has issued a voluntary nationwide recall of Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5mg/500mg. The lots are being recalled because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5mg/500mg, 1000 count label. The following lots are being recalled: Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration. Butalbital, Acetaminophen, and Caffeine is used to treat migraines. These combination tablets are made by many different manufacturers and are sold under other names including Esgic-Plus and Fioricet. Hydrocodone Bitartrate and Acetaminophen is used for moderate to severe pain. These combination tablets are made by many different manufacturers and are also sold under other names such as Anexsia, Co-Gesic, Lortab, Norco, and Vicodin. This recall alert only applies to the select lots of the generic Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg and Hydrocodone Bitartrate and Acetaminophen Tablets, 10mg / 500mg from Qualitest. No other Butalbital, Acetaminophen, and Caffeine or Hydrocodone Bitartrate and Acetaminophen products are involved in this recall. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm260837.htm
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Date Published Title Drug Source
2011-06-30 McNeil Recalls Single Lot of Tylenol Extra Strength Caplets, 225 count Acetaminophen Manufacturer
2011-06-28 Qualitest Recalls Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets Butalbital FDA
2011-06-27 Endo Pharmaceuticals Recalls Endocet Bottles With Wrong Pill Sizes Acetaminophen with Oxycodone Manufacturer
2011-06-27 Rugby Recalls Children's Pain & Fever Concentrated Drops Due To Problems With Child-Resistant Closure Acetaminophen Manufacturer
2011-06-24 FDA Modifies Dosing Recommendations for Erythropoiesis-Stimulating Agents Epoetin Alfa FDA
2011-06-24 New Study: Combining Commonly Used Drugs Linked to a Greater Risk of Death and Declining Brain Function Beclomethasone MediGuard CRT
2011-06-23 New Study Suggests High-Dose Statins May Cause Diabetes Atorvastatin MediGuard CRT
2011-06-18 Ortho-McNeil Voluntarily Recalls Two Lots: Risperdal (Risperidone) 3mg and Risperidone 2mg Risperidone Manufacturer
2011-06-16 FDA Warns: Chantix (varenicline) May Increase the Risk of Heart Attack, Angina and Other Heart-Related Adverse Events in Patients with Cardiovascular Disease Varenicline FDA
2011-06-15 FDA Issues Safety Update for Ongoing Safety Review of Actos (Pioglitazone) and Increased Risk of Bladder Cancer Glimepiride and Pioglitazone FDA
2011-06-15 Bristol-Myers Squibb Expands May 2011 Recall: More Tablet Strengths Recalled Warfarin Manufacturer
2011-06-14 Endo Pharmaceuticals Recalls Single Lot of Percocet 10 mg/325 mg Acetaminophen with Oxycodone FDA
2011-06-14 FDA Issues Warning About Medication Errors Due to Name Confusion Between Risperidone (Risperdal) and Ropinirole (Requip) Risperidone FDA
2011-06-13 Healthcare Providers Reminded About Risks With Victoza Liraglutide FDA
2011-06-09 FDA Issues Drug Safety Communication: Finasteride (Proscar, Propecia), Dutasteride (Avodart, Jalyn) May Increase the Risk of a More Serious Form of Prostate Cancer Finasteride FDA
2011-06-08 FDA Limits Use of 80 mg Simvastatin Simvastatin FDA
2011-06-06 Lupin Pharmaceuticals Inc. Recalls Several Lots of Perindopril 2 mg Tablets Perindopril FDA
2011-06-02 FDA Completes Safety Review: Angiotensin Receptor Blockers (ARBs) for High Blood Pressure Do Not Increase Risk of Cancer Telmisartan FDA
2011-06-01 Sandoz Inc. Recalls Single Lot of Metformin Hydrochloride Tablets 1000 mg Metformin FDA
2011-06-01 Teva Pharmaceuticals Recalls Single Lot of Lansoprazole Delayed-Release Capsules USP, 30 mg Lansoprazole FDA