CLASS II ONGOING Drug recall · Reported 29 Oct 2025 · FDA Enforcement Report
Niacin Extended-release Tablets, USP, 1,000 mg recalled
Lannett is recalling Niacin Extended-release Tablets, USP, 1,000 mg, distributed nationwide in the US. The recall was initiated on 10 Oct 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-0096-2026
- FDA event ID
- 97778
- Recalling firm
- Lannett, Seymour, IN
- Brand
- Niacin
- Manufacturer
- Lannett Company, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Oct 2025
- FDA classified
- 22 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 10 Oct 2025 | Recall initiated by company | |
| 22 Oct 2025 | Classified by FDA | +12 days |
| 29 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026
Where was it sold?
Nationwide in 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 Lannett
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dextroamphetamine Saccharate recalled by Lannett CompanyDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett | Packaging Defects | Nationwide |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS III | Primidone Tablets USP, 250mg recalled by Lannett CompanyPrimidone | Lannett | Other | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett | Other | OH |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 40 mg recalled by Lannett CompanyLisdexamfetamine Dimesylate | Lannett | Packaging Defects | Nationwide |
Other Niacin recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin | Golden State Medical Supply | Potency & Assay | CA |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS II | Niacin Extended-Release Tablets, USP, 1,000 mg recalledNiacin | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Niacin Extended-Release Tablets, USP 1000mg recalledNiacin | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Niacin Extended-Release Tablets, USP 500mg recalledNiacin | SUN Pharmaceutical Industries | Sterility | Nationwide |