CLASS I Drug recall · Reported 10 Oct 2018 · FDA Enforcement Report
robaxin-750 (methocarbamol tablets, USP), 750 mg recalled
Endo Pharmaceuticals is recalling robaxin-750 (methocarbamol tablets, USP), 750 mg, distributed nationwide in the US. The recall was initiated on 17 Sep 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0009-2019
- FDA event ID
- 81034
- Recalling firm
- Endo Pharmaceuticals, Malvern, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Sep 2018
- FDA classified
- 9 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 17 Sep 2018 | Recall initiated by company | |
| 9 Oct 2018 | Classified by FDA | +22 days |
| 10 Oct 2018 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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."
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
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."
Which lots are affected?
Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Endo Pharmaceuticals
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Clonazepam Orally Disintegrating Tablets recalledClonazepam | Endo Pharmaceuticals | Labeling Errors | Nationwide |
| Drug | CLASS II | Calcitonin Salmon Nasal Spray recalled by Endo PharmaceuticalsCalcitonin Salmon | Endo Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Edex (alprostadil for injection) 10mcg recalled by Endo PharmaceuticalsEdex | Endo Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS III | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg recalled | Endo Pharmaceuticals | Other | Nationwide |