FDA Drug recall D-0354-2025
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Some…
- FDA Drug
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Some… by Somerset Therapeutics Private, citing lack of Assurance of Sterility: Media fill with bacterial contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0354-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-21 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Somerset Therapeutics Private |
| Distribution | US |
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)
Reason
Lack of Assurance of Sterility: Media fill with bacterial contamination
Identifiers
| ndc | 70069-101-25 |
|---|---|
| ndc | 70069-101-10 |
| ndc | 70069-101-05 |
| code_info | NDC 70069-101-25; A240304, A240305, A240320, A240322, A240334, A240335, A240340, exp. date 05/2026; A240342, A240347,…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0354-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.