CLASS II ONGOING Drug recall · Reported 24 Dec 2025 · FDA Enforcement Report
Baclofen Tablets USP, 10 mg recalled by Golden State Medical Supply
Golden State Medical Supply is recalling Baclofen Tablets USP, 10 mg, distributed nationwide in the US. The recall was initiated on 26 Nov 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0235-2026
- FDA event ID
- 98059
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Brand
- Baclofen
- Manufacturer
- Golden State Medical Supply, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Nov 2025
- FDA classified
- 15 Dec 2025
- Reported
- 24 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 26 Nov 2025 | Recall initiated by company | |
| 15 Dec 2025 | Classified by FDA | +19 days |
| 24 Dec 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules
Product as listed by the FDA
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Where it was distributed
Nationwide within the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
Lot GS065762
Where was it sold?
Nationwide within the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Golden State Medical Supply
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalledCarbamazepine | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin | Golden State Medical Supply | Potency & Assay | CA |
| Drug | CLASS III | Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
Other Baclofen recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Baclofen 2000MCG/ML INJ in syringe Assurance Infusion (713) recalled | Assurance Infusion | Sterility | Nationwide |
| Drug | CLASS II | Baclofen and Clonidine HCL and Morphine Sulfate recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
| Drug | CLASS II | Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe recalledGablofen | Piramal Critical Care | Potency & Assay | Nationwide |
| Drug | CLASS II | Baclofen 5000 mcg/ml, vol recalled by Hartley Medical Center | Hartley Medical Center Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Baclofen 2000 mcg/ml, vol recalled by Hartley Medical Center | Hartley Medical Center Pharmacy | Sterility | Nationwide |