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Medication Safety Alerts

Robaxin® 750 mg tablets Voluntary Recall

September 28, 2018

On September 28, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of Robaxin® 750 mg tablets manufactured by Endo Pharmaceuticals. This recall was issued because the product has the wrong daily dosing information on the manufacturer’s label that reads the daily dose as "two to four tablets four times daily" instead of the correct dosage of "two tablets three times daily." If plan members follow the directions on the manufacturer’s bottle they may have significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death. If plan members follow the directions on their pharmacy’s label, then they should not have problems related to this recall.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects lot numbers 220409P1 exp. 01/31/21 and 216702P1 exp. 09/30/20. If your product was dispensed in the manufacturer’s bottle, please check the lot number. The lot number is on the manufacturer’s bottle. If your product is not from one of these affected lots, it is not affected by this recall.

This recall was issued because the product has the wrong daily dosing information on the manufacturer’s label that reads the daily dose as "two to four tablets four times daily" instead of the correct dosage of "two tablets three times daily." Please note that there is nothing wrong with the product as long as you follow the dosing instructions on the pharmacy label as prescribed by your doctor.

Please call your doctor right away for advice if you are or believe you may be taking your medicine incorrectly. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: If you are currently taking Robaxin 750 mg tablets, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently taking Robaxin 750 mg tablets and have questions regarding this recall, please call your doctor or call Inmar toll-free at 1-866-391-0620, Monday through Friday, 9:00 am to 5:00 pm (ET). You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.

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