November 2025 FDA Recall Baclofen by Golden State Medical Supply Inc.
D-0235-2026 - Presence of Foreign Tablets/Capsules
This Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on November 26, 2025 for the product Baclofen. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0235-2026
Presence of Foreign Tablets/Capsules
11-26-2025
12-24-2025
2472 HDPE Bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Golden State Medical Supply Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Batch or Lot Expiration Information
Lot# Lot GS065762
