Methocarbamol Injection USP 1 recall
FDA recall D-0354-2025 · initiated Mar 21, 2025
Somerset Therapeutics Private Limited recalled Methocarbamol Injection USP 1 in Mar 2025 — an FDA Class II recall (D-0354-2025) because Lack of Assurance of Sterility: Media fill with bacterial contamination.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Media fill with bacterial contamination
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 506,080 vials
Details
- Product
- Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)
- Recalling company
- Somerset Therapeutics Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Mar 21, 2025
- FDA report date
- Apr 16, 2025
Frequently asked
- Was Methocarbamol Injection USP 1 recalled?
- Somerset Therapeutics Private Limited recalled Methocarbamol Injection USP 1 in Mar 2025 — an FDA Class II recall (D-0354-2025) because Lack of Assurance of Sterility: Media fill with bacterial contamination. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Methocarbamol Injection USP 1 recalled?
- Per the FDA enforcement record, the reason for recall D-0354-2025 was: Lack of Assurance of Sterility: Media fill with bacterial contamination
- Is a recalled Methocarbamol Injection USP 1 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Methocarbamol Injection USP 1 are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — 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, exp. date 05/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0354-2025.