Baclofen Tablets USP recall
FDA recall D-0235-2026 · initiated Nov 26, 2025
Golden State Medical Supply Inc. recalled Baclofen Tablets USP in Nov 2025 — an FDA Class II recall (D-0235-2026) because Presence of Foreign Tablets/Capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Tablets/Capsules
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2472 HDPE Bottles
Details
- Product
- Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
- Recalling company
- Golden State Medical Supply Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA
- Initiated
- Nov 26, 2025
- FDA report date
- Dec 24, 2025
Frequently asked
- Was Baclofen Tablets USP recalled?
- Golden State Medical Supply Inc. recalled Baclofen Tablets USP in Nov 2025 — an FDA Class II recall (D-0235-2026) because Presence of Foreign Tablets/Capsules. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Baclofen Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0235-2026 was: Presence of Foreign Tablets/Capsules
- Is a recalled Baclofen Tablets USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Baclofen Tablets USP are affected?
- Distributed: Nationwide within the USA. The recall covers these lots — Lot GS065762. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0235-2026.