Drug Safety Alerts

Robaxin® 750 mg tablets Consumer-Level Recall

9/28/18

On September 28, 2018, the United States Food and Drug Administration (FDA) issued a MedWatch regarding a consumer-level recall of Robaxin^® 750 mg tablets manufactured by Endo Pharmaceuticals. This recall was issued because the product has been found to have incorrect daily dosing information on the manufacturer’s label which misstates the daily dose as "twoto four tablets four times daily" rather than the correct dosage of "two tablets three times daily." Patients who follow the directions on the manufacturer’s 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. Patients who follow their prescriber’s instructions on their pharmacy’s label should not experience any issues related to this recall. To date, Endo Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

This recall affects lot numbers 220409P1 exp. 01/31/21 and 216702P1 exp. 09/30/20. The affected lots went into distribution on January 18, 2018.

This recall was originally received on September 21, 2018 as a retail-level recall. The FDA advised that this was elevated to the consumer-level on September 28, 2018.

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Robaxin 750 mg tablets to contact their prescriber.

For more information about this recall, health care providers may contact Inmar at 1-866-391-0620, Monday through Friday, 9:00 am to 5:00 pm (ET). You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.