HIGHFDA DRUG

Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
May 27, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 27, 2026
Hazard Level
HIGH
Brands
NIACIN, Lannett Company, Inc.
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
NIACIN, Lannett Company, Inc.
Model numbers
Lot #: 25282724A, Exp. Date 2027/01
UPC codes
62175-320, 62175-322, 62175-320-46, 62175-320-43, 62175-322-46, 62175-322-43
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 27, 2026

  2. Reported by FDA DRUG

    June 10, 2026

  3. RecallRadar source check

    June 16, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

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

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Full Description

Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.. Generic: NIACIN; Brand: NIACIN. Reason: Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.. Classification: Class II. Quantity: 3984 bottles. Distribution: Nationwide within the United States

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot #: 25282724A
Exp. Date 2027/01
UPC Codes
62175-320
62175-322
62175-320-46
+3 more
Affected States
ALL
Report Date
June 10, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE