FDA Recall D-0354-2025

Somerset Therapeutics Private Limited · Bengaluru, N/A

Class II Ongoing 419 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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)

Lot / code: 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

Quantity: 506,080 vials

Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Recall record

Recall number: D-0354-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-03-21
Classified by FDA Center: 2025-04-08
FDA published: 2025-04-16
Recalling firm: Somerset Therapeutics Private Limited
Firm location: Bengaluru, N/A, India

Drug identification

Brand name(s): METHOCARBAMOL
Generic name(s): METHOCARBAMOL
Manufacturer(s): Somerset Therapeutics, LLC
NDC(s): 70069-101
Route(s): INTRAMUSCULAR, INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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