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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Niacin Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: October 22, 2025
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Summary

Lannett Company Inc. has recalled 46,848 bottles of Niacin (nicotinic acid) 1,000 mg Extended-release Tablets because the medication failed dissolution specifications. This means the tablets may not break down or release the medication at the proper rate, which can affect how the drug is absorbed into the body. These prescription tablets were distributed nationwide in 90-count bottles and were manufactured in the United States.

Risk

If the tablets do not dissolve correctly, the medication may be released too slowly or too quickly, potentially leading to ineffective treatment of high cholesterol or unexpected side effects from incorrect dosing levels.

What You Should Do

  1. Check your prescription bottle for Niacin Extended-release Tablets, 1,000 mg (NDC 62175-322-46) with any of the following lot numbers: 21264027A, 22266446A, 22266901A, 22267553A, 22267554A, 22267555A, 22267992A, 22267993A, or 22267994A.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Niacin Extended-release Tablets, USP (90-count bottle)
Variants: 1,000 mg, Extended-release
Lot Numbers:
21264027A (Exp 10/30/2025)
22266446A (Exp 12/31/2025)
22266901A (Exp 02/28/2026)
22267553A (Exp 03/31/2026)
22267554A (Exp 03/31/2026)
22267555A (Exp 02/28/2026)
22267992A (Exp 04/30/2026)
22267993A (Exp 05/31/2026)
22267994A (Exp 05/31/2026)
NDC:
62175-322-46

Recall #: D-0096-2026; Distributed by Lannett Company, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97778
Status: Active
Manufacturer: Lannett Company Inc.
Sold By: pharmacies; wholesalers
Manufactured In: United States
Units Affected: 46,848 90-count bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.