Endo Pharmaceuticals Recalls Robaxin-750 Due to Incorrect Dosage Labeling
Endo Pharmaceuticals is recalling 2,856 bottles of Robaxin-750 (methocarbamol) because the labels contain incorrect dosage instructions.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, but the hazard is a labeling error regarding dosage instructions rather than a contamination or structural defect. Per the rubric, minor labeling errors and voluntary precautionary recalls are typically rated as Moderate (2), as the risk is theoretical and no injuries are reported.
Plain-English summary
Endo Pharmaceuticals, Inc. is recalling 2,856 bottles of Robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottles. The product is distributed nationwide in the USA. The recall involves specific lots: 216702P1 (Exp 09/20) and 220409P1 (Exp 01/21).
The recall was initiated due to a labeling error. The immediate container labels incorrectly state the dosage as "Two to four tablets four times daily." The correct dosage is "Two tablets three times daily."
Consumers who have this product should check their bottles for the affected lot numbers and expiration dates. If the product matches the recalled lots, they should stop using it and contact their healthcare provider or pharmacist for guidance on the correct dosage.
The recalled product
- 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.
- Manufacturer
- Endo Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 2,856
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 216702P1
- Exp 09/20
- 220409P1
- Exp 01/21
Distribution
Distributed nationwide across the United States.
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