Methocarbamol injection recalled for lack of sterility assurance

Plain-English summary

Somerset Therapeutics is recalling methocarbamol injection USP (1,000 mg/10 mL) nationwide due to a lack of assurance of sterility. During manufacturing validation testing (media fill), bacterial contamination was detected, indicating the manufacturing process did not maintain the required sterile conditions.

The recall affects 506,080 vials with NDC 70069-101-25 and 70069-101-05. Multiple lot codes are affected with expiration dates in May and June 2026.

Methocarbamol is a muscle relaxant administered by intramuscular or intravenous injection. Patients who received doses from affected batches could potentially be exposed to bacterial contamination, which poses a serious risk for injectable medications.

Patients or healthcare providers who have received or dispensed doses from the affected lots should stop using them immediately and contact their healthcare provider. No illnesses or injuries have been reported to date.

The recalled product

Product

METHOCARBAMOL (METHOCARBAMOL)

Brand

METHOCARBAMOL

Manufacturer

Somerset Therapeutics Private Limited

Category

Drug — Injectable / Muscle Relaxant

Hazard

• lack-of-sterility
• bacterial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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