Methocarbamol Injection USP Recalled Due to Sterility Assurance Concerns
Somerset Therapeutics is recalling Methocarbamol Injection USP (1,000 mg/10 mL vials) nationwide due to lack of assurance of sterility following bacterial contamination in media fill testing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile injectable drug with confirmed bacterial contamination in manufacturing validation (media fill). Lack of sterility assurance in parenteral medications presents significant risk of serious infection, meeting the Severe (4) threshold per the rubric.
Plain-English summary
Somerset Therapeutics Private Limited is recalling Methocarbamol Injection USP, 1,000 mg/10 mL (100 mg/mL) in 10 mL single-dose vials, nationally. The recall was initiated due to lack of assurance of sterility, specifically because bacterial contamination was detected during media fill testing.
Methocarbamol is a muscle relaxant administered by intramuscular or intravenous injection. The affected product was manufactured for Somerset Therapeutics, LLC in Somerset, New Jersey. A total of 506,080 vials are subject to this recall.
Affected lot codes include: NDC 70069-101-25 lots A240304, A240305, A240320, A240322, A240334, A240335, A240340 (expiration 05/2026); A240342, A240347, A240385, A240391 (expiration 06/2026). NDC 70069-101-05 lot A240326 (expiration 05/2026) is also affected.
Patients and healthcare providers should stop use of the recalled product and consult their healthcare provider about alternative treatment options. Unused vials should not be used. Healthcare facilities should quarantine and return the recalled product to Somerset Therapeutics. The FDA is monitoring this Class II recall.
The recalled product
- Product
- METHOCARBAMOL (METHOCARBAMOL)
- Brand
- METHOCARBAMOL
- Manufacturer
- Somerset Therapeutics Private Limited
- Affected units
- 506,080
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 (16)
- NDC 70069-101-25
- A240304
- A240305
- A240320
- A240322
- A240334
- A240335
- A240340
- exp. date 05/2026
- A240342
- A240347
- A240385
- A240391
- exp. date 06/2026
- NDC 70069-101-05
- A240326
UPCs (4)
- 0370069101018
- 0370069101100
- 0370069101254
- 0370069101056
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Somerset Therapeutics Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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