Drug FDA Class II Ongoing Foreign material

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

Golden State Medical Supply Inc. Published Dec 24, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Golden State Medical Supply Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Presence of Foreign Tablets/Capsules

Hazards

Foreign Tablets/Capsules · primary

Affected products (1)

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

BACLOFEN · 2472 HDPE Bottles

NDC: 51407-972, 51407-973, 51407-974, 51407-972-01, 51407-973-01, 51407-973-10, 51407-974-01, 51407-974-10

Lot codes: GS065762

Code info: Lot GS065762

Affected areas

Nationwide

Timeline

Initiated

Nov 26, 2025
Published

Dec 24, 2025

Recall number: D-0235-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.