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.
The agency’s classification
FDA (Drugs): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason 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.""
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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