FDA Class I Recall: Methocarbamol Injection for Particulate Matter
Eugia US LLC is recalling Methocarbamol Injection nationwide due to particulate matter contamination. The FDA classified this as a Class I recall affecting lot 3MC23011 (expiration 11/30/2026).
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: FDA Class I recalls are the agency's most serious classification, indicating a reasonable probability that use will cause serious adverse health consequences. Per the rubric, FDA Class I recalls are never scored below 4. No reported illnesses or deaths are mentioned in the source, preventing a score of 5.
Plain-English summary
Eugia US LLC is recalling Methocarbamol Injection, USP 1000 mg/10 mL, due to the presence of particulate matter. The FDA has classified this as a Class I recall—the most serious classification—indicating a reasonable probability that use of this product may cause serious adverse health consequences.
The affected product is lot 3MC23011 with an expiration date of 11/30/2026. Approximately 1,552 cartons, each containing 25 single-dose vials, were distributed nationwide. The product's NDC number is 55150-223-10.
Methocarbamol is a centrally-acting muscle relaxant administered by intramuscular or intravenous injection. The presence of particulate matter in injectable medications poses a potential risk to patients receiving these injections.
Patients and healthcare providers with vials from the affected lot should stop use immediately and consult with a healthcare provider regarding appropriate next steps.
The recalled product
- Product
- METHOCARBAMOL (METHOCARBAMOL)
- Brand
- METHOCARBAMOL
- Manufacturer
- Eugia US LLC
- Category
- Drug — Injectable
- Hazard
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 (2)
- Lot #: 3MC23011
- Exp 11/30/2026
Distribution
Distributed nationwide across the United States.
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