Safety Alerts & Recalls

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Latest Alerts

Illegal Botox Scammers
The FDA recently released a report about an investigation of 210 health care professionals across the United States who purposely injected an unapproved, cheaper substitute toxin for FDA-approved Botox Cosmetic which resulted in paralysis of several patients. For more information please visit: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048377.htm
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New Boxed Warning
In a follow up to the safety review conducted in early 2008, the FDA is requiring manufacturers to change the labeling for botulinum products, including BOTULINUM TOXIN TYPE A (BOTOX, BOTOX COSMETIC), to include a boxed warning about the risk of adverse events when the effects of the toxin spread beyond the injection site. For more information, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149574.htm
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Date Published Title Drug Source
2008-08-21 Illegal Botox Scammers Onabotulinumtoxina FDA
2009-05-01 New Boxed Warning Onabotulinumtoxina FDA
2009-08-04 FDA Approves Updated Labeling for Botulinum Products Onabotulinumtoxina FDA
2009-01-29 Recall on All ETHEX Brand Ondansetron Tablets Ondansetron Manufacturer
2011-09-16 FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of Zofran (Ondansetron) Ondansetron FDA
2012-07-24 FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of High Dose Zofran (Ondansetron) Ondansetron FDA
2009-08-24 Early Communication about an Ongoing Safety Review for Orlistat (marketed as Alli and Xenical) Orlistat FDA
2010-01-18 FDA Warns Consumers About Counterfeit Alli Orlistat FDA
2010-01-26 Update on FDA Warning About Counterfeit Alli Orlistat FDA
2010-05-27 FDA Completes Safety Review of Xenical/Alli (Orlistat) and Severe Liver Injury Orlistat FDA
2014-03-31 GlaxoSmithKline Reports Product Tampering With alli® Orlistat Manufacturer
2008-01-18 Product label updated with new information about VTE risk Ortho Evra FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Ortho Evra FDA
2011-07-13 CDC Revises Recommendations for the Use of Birth Control Methods During the Initial Period After Childbirth MediGuard CRT
2009-09-25 Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors Oseltamivir FDA
2009-11-04 FDA Answers Common Questions about Tamiflu Oseltamivir FDA
2010-06-18 FDA Warns That Generic Tamiflu From Internet Is Fake and Could Be Harmful Oseltamivir FDA
2008-08-13 Heart risks with calcium supplements in healthy post-menopausal women MediGuard CRT
2012-01-18 Rexall, Inc Issues Allergy Alert and Recall of Single Lot of Calcium 1200mg plus Vitamin D 1000 IU Softgels FDA
2011-07-19 King Pharmaceuticals Recalls Single Lot of Cortisporin Otic Solution Otosporin FDA
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