Endo Pharmaceuticals Recalls Robaxin Due to Incorrect Dosing Label

Endo Pharmaceuticals Recalls Robaxin Due to Incorrect Dosing Label

Endo Pharmaceuticals is voluntarily recalling two lots of Robaxin (methocarbamol tablets) due to incorrect daily dosing information on the label, which misstates the daily dose as “two to four tablets four times a day,” which could result in 16 tablets, rather than the correct dosage of “two tablets three times daily,” which results in 6 tablets.

Robaxin is a muscle relaxant that contains the active ingredient methocarbamol. The drug is indicated as an adjunct therapy to rest, physical therapy and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.

Patients who follow the directions on the bottle may experience significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death.

The recall includes the following product lots:

  • Robaxin® 750mg, 100 Count Bottle pack, Lot 216702P1, Expiration Date: September 2020
  • Robaxin® 750mg, 100 Count Bottle pack, Lot 220409P1, Expiration Date: January 2021.

Distributors and retailers that have product which is being recalled should stop distributing and dispensing and return to the place of purchase.

For further information, read the FDA recall notice.