Quick Facts at a Glance
- Recall Date
- October 10, 2025
- Hazard Level
- HIGH
- Brands
- Lannett, NIACIN
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Lannett, NIACIN
- Product type
- Extended-release Niacin Tablet 1000 mg
- Model numbers
- 21264027A, 22266446A, 22266901A, 22267553A, 22267554A, 22267555A, 22267992A, 22267993A +1 more
- UPC codes
- 62175-320, 62175-322, 62175-320-46, 62175-320-43, 62175-322-46, 62175-322-43
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 10, 2025
Reported by FDA DRUG
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Dissolution Specifications
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Lannett Company Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
NIACIN Extended-release tablets are a prescription-grade form of vitamin B3 used to treat cholesterol and other conditions under medical supervision. The product discussed is 1,000 mg per tablet and distributed nationwide in 90-tablet bottles.
Why This Is Dangerous
The dissolution failure means the tablet may not dissolve properly in the stomach, potentially reducing therapeutic effect and leading to ineffective treatment.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Consumers may require alternatives or adjustments to therapy. The recall impacts patients relying on prescribed Niacin ER without assurance of dissolution performance until guidance is provided.
Practical Guidance
How to identify if yours is affected
- 1. Locate NDC 62175-322-46 on your NIACIN bottle.
- 3. Review expiration dates: 10/30/2025 onward through 05/31/2026.
- 4. If your bottle matches any of these identifiers, stop using it and contact the manufacturer for guidance.
Where to find product info
Label on the bottle shows NDC, lot number, and expiration date. The official recall notice will provide refund or replacement instructions.
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks after proof of purchase or return is received.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- File a complaint with the FDA if the company does not respond within a reasonable time.
- Consider legal counsel if significant injuries or losses occur and the company remains unresponsive.
How to prevent similar issues
- Always verify NDC and lot numbers when receiving prescription medications.
- Compare recall numbers with FDA notices and maintain a record of batch information.
- Ask pharmacists about safety alerts when starting or continuing therapy.
Documentation advice
Keep the original bottle, packaging, and recall notice. Photograph the label showing NDC, lot, and expiration. Save receipts and correspondence with the manufacturer.
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Product Details
NDC: 62175-322-46. Pack: 90 tablets per bottle. Quantity recalled: 46,848 bottles. Distribution: Nationwide in the USA. Sold as NIACIN Extended-release Tablets, 1,000 mg, Rx Only. Lot numbers and expirations include: 21264027A Exp 10/30/2025; 22266446A Exp 12/31/2025; 22266901A Exp 02/28/2026; 22267553A Exp 03/31/2026; 22267554A Exp 02/28/2026; 22267555A Exp 02/28/2026; 22267992A Exp 04/30/2026; 22267993A; 22267994A Exp 05/31/2026.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Expiry dates: 10/30/2025 to 05/31/2026
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Safety Guide
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