Recalls / Class II
Class IID-0354-2025
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)
- Brand name
- Methocarbamol
- Generic name
- Methocarbamol
- Active ingredient
- Methocarbamol
- Route
- Intramuscular, Intravenous
- NDC
- 70069-101
- FDA application
- ANDA207522
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recalling firm
- Firm
- Somerset Therapeutics Private Limited
- Manufacturer
- Somerset Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 54/1 Budihal Village, N/A, Bengaluru, N/A N/A, India
Distribution
- Quantity
- 506,080 vials
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-21
- FDA classified
- 2025-04-08
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0354-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.