robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo...

FDA Drug Recall #D-0009-2019 — Class I — September 17, 2018

Recall Summary

Recall Number D-0009-2019
Classification Class I — Serious risk
Date Initiated September 17, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Endo Pharmaceuticals, Inc.
Location Malvern, PA
Product Type Drugs
Quantity 2,856 bottles

Product Description

robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.

Reason for Recall

Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."

Distribution Pattern

Nationwide in the USA.

Lot / Code Information

Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21

Other Recalls from Endo Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0622-2024 Class I Clonazepam Orally Disintegrating Tablets, USP (... Jul 10, 2024
D-0475-2023 Class II Calcitonin Salmon Nasal Spray, USP, 2200 Intern... Mar 2, 2023
D-0512-2017 Class II Edex (alprostadil for injection) 10mcg, package... Feb 22, 2017
D-1381-2012 Class III Endocet (oxycodone and acetaminophen) tablets, ... May 7, 2012

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.