Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Nov 26, 2025 (11 months ago)

Baclofen Tablets USP

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Tablets/Capsules

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

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

Affected NDC 51407-0973-10

Compare with the code on your package — it is the most precise check available.

Drug: Baclofen

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Baclofen
NDC 51407-0973
10 mg/1 Tablet
Oral
Golden State Medical Supply, Inc. Rx
Recalling firm
Golden State Medical Supply Inc.
NDC code
51407-973-10
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0235-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Baclofen recalls

See all

Other recalls by Golden State Medical Supply Inc.

All 2025 recalls
Class II · Moderate risk

Prasugrel HCI

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

Ongoing Dissolution failure Golden State Medical Supply Inc. D-0847-2026
Class II · Moderate risk

Carbamazepine Tablets

CGMP deviations: tablets with black specks.

Ongoing cGMP deviation Golden State Medical Supply Inc. NDC 51407-215-10 D-0771-2026
Class II · Moderate risk

GSMS Incorporated

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.

Ongoing Dissolution failure Golden State Medical Supply Inc. NDC 51407-268-90 D-0587-2026
Class III · Low risk

Primidone Tablets

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Ongoing Cross-contamination Golden State Medical Supply Inc. NDC 51407-638-01 D-0535-2026