# FDA recall D-0009-2019

> **Endo Pharmaceuticals, Inc.** · Class I · drug recall initiated 2018-09-17.

## 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."

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0009-2019
- **Recalling firm:** Endo Pharmaceuticals, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-17
- **Report date:** 2018-10-10
- **Termination date:** 2020-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2019

## Citation

> AI Analytics. FDA recall D-0009-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0009-2019. Source: US FDA. Licensed CC0.

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