Niacin Extended-Release Tablets Recalled for Failed Dissolution Specifications
Golden State Medical Supply is recalling 24,869 bottles of Niacin Extended-Release 1,000 mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly in the body, potentially affecting medication effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a prescription medication with failed dissolution specifications. No illnesses or injuries have been reported, but tablets that do not dissolve properly pose a risk to therapeutic efficacy, fitting the criterion for risk-of-harm products without reported injury.
Plain-English summary
Golden State Medical Supply, Inc. is recalling 24,869 bottles of Niacin Extended-Release Tablets, USP, 1,000 mg throughout the United States. The recall affects multiple lot numbers with expiration dates ranging from October 2025 through May 2026.
The tablets have failed to meet dissolution specifications. This means the tablets may not dissolve properly in the gastrointestinal tract, which could affect how effectively the medication is absorbed and utilized by the body.
Patients currently taking affected tablets should consult their healthcare provider or pharmacist to determine if their medication is part of this recall. Do not stop taking niacin without first speaking to your doctor, as abrupt discontinuation could impact your health. Healthcare providers should review patients' prescriptions and contact information to notify them if their medication is affected.
Consumers with affected bottles should contact their pharmacy or healthcare provider immediately.
The recalled product
- Product
- NIACIN (NIACIN)
- Brand
- NIACIN
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug
- Hazard
- failed-dissolution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot
- expiry: GS044385
- exp 10/2025
- GS044979
- GS045797
- exp 12/2025
- GS046415
- GS047197
- exp 02/2026
- GS047786
- GS048477
- GS049480
- exp 03/2026
- GS048873
- GS049733
- GS050224
- GS050721
- GS050722
- GS051145
- GS051726
Distribution
Distributed nationwide across the United States.
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