robaxin-750 — Class I drug recall D-0009-2019
Terminated recall by Endo Pharmaceuticals, Inc., reported 2018-10-10, distributed nationwide. Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two
| Recall number | D-0009-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endo Pharmaceuticals, Inc., Malvern, PA, United States |
| Recall initiated | 2018-09-17 |
| Classified | 2018-10-09 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2020-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 2,856 bottles |
| Reason classes | labeling |
| NDC | 52244-0449-10 |
| Lot numbers | 01/21, 09/20, 216702P1, 220409P1 |
Product
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."
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0009-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.