Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 930...

FDA Recall #D-0235-2026 — Class II — November 26, 2025

Recall #D-0235-2026 Date: November 26, 2025 Classification: Class II Status: Ongoing

Product Description

Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10

Reason for Recall

Presence of Foreign Tablets/Capsules

Recalling Firm

Golden State Medical Supply Inc. — Camarillo, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2472 HDPE Bottles

Distribution

Nationwide within the USA

Code Information

Lot GS065762

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated