Robaxin 750mg Tablets
Date of Recall: September 28, 2018
Recalling Firm(s): Endo Pharmaceuticals
Products: Robaxin 750mg Tablets, 100 Count Bottle pack.
Scope of Recall: Lot 216702P1 and Lot 220409P1. No other lots of Robaxin are affected by this recall.
Description: Endo Pharmaceuticals initiated a recall for two lots of Robaxin (methocarbamol tabelts, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have the incorrect daily dosing on the label due to a labeling error. This labeling error misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.” Patients who follow the directions may experience significant drowsiness and/or dizziness, which may put them at risk of falls or an overdose which can result in seizures, coma, or possibly death. To date, Endo Pharmaceuticals has not received any reports of adverse reactions related to this recall.
For more information, please see the safety announcement posted on the FDA website. https://www.fda.gov/Safety/Recalls/ucm622008.htm