Food, drugs, devices › Endo Pharmaceuticals, Inc.
Drug recall: robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc.,
FDA enforcement event 81034 is a drug recall by Endo Pharmaceuticals, Inc. of Malvern, PA, initiated 17 Sep 2018 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 11% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 4 Feb 2020. Initiation: voluntary: firm initiated. Endo Pharmaceuticals, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Endo Pharmaceuticals, Inc., Malvern, PA.
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
"Nationwide in the USA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0009-2019 | 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. | 2,856 bottles | Class I | Terminated | 10 Oct 2018 |
Context
Other enforcement events for Endo Pharmaceuticals, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Jul 2024 | Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 table | Drug | Class I | 1 |
| 2 Mar 2023 | Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 | Drug | Class II | 1 |
| 22 Feb 2017 | Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharm | Drug | Class II | 1 |
| 7 May 2012 | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured fo | Drug | Class III | 1 |
All 5 events for Endo Pharmaceuticals, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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.""
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Feb 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.