Topamax Recall Issued Due to Foul Odor

A Topamax recall of approximately 57,000 bottles of the migraine and seizure medication was issued after four consumers complained of a foul odor. According to the FDA recall announcement, the odor is not toxic, but may cause temporary gastrointestinal symptoms. No serious adverse events have been reported due to the presence of the uncharacteristic odor, which is thought be caused by small amounts of TBA.

The Topamax recall, announced on April 15, 2011, was only issued due to the musty odor, and not because of the increased risk of Topamax birth defects. Approximately one month before the Topamax recall was issued, the FDA warned the public of new data which revealed an increased risk of Topamax birth defects in infants born to women taking the drug during pregnancy. As a result of the data, the agency also reclassified the drug into Pregnancy Category D, indicating that human research revealed that the drug could potentially harm an unborn child.

While a Topamax recall has not been issued due to the birth defect risk, legal recourse may still be available to women who took Topamax during pregnancy and delivered children with cleft lips or cleft palates. Learn more about Topamax birth defects and complete our free case evaluation form on the right to find out if you can participate in a Topamax lawsuit to recover compensation for damages.