FDA DrugsClass II
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distr...
Published: June 10, 2026Recall ID: D-0584-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Seymour |
| State | IN |
| Openfda › Nui › 1 | N0000175594 |
| Openfda › Nui › 2 | M0014839 |
| Openfda › Upc | 0362175320469 |
| Openfda › Unii | 2679MF687A |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1098134 |
| Openfda › Rxcui › 2 | 1098141 |
| Openfda › Spl id | 7e9530d1-a940-42e8-b754-0d4089b39db1 |
| Openfda › Brand name | NIACIN |
| Openfda › Spl set id | d7b66e13-00ed-48a9-a54a-8e474cc31d54 |
| Openfda › Package ndc › 1 | 62175-320-46 |
| Openfda › Package ndc › 2 | 62175-320-43 |
| Openfda › Package ndc › 3 | 62175-322-46 |
| Openfda › Package ndc › 4 | 62175-322-43 |
| Openfda › Product ndc › 1 | 62175-320 |
| Openfda › Product ndc › 2 | 62175-322 |
| Openfda › Generic name | NIACIN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Nicotinic Acids [CS] |
| Openfda › Substance name | NIACIN |
| Openfda › Pharm class epc | Nicotinic Acid [EPC] |
| Openfda › Manufacturer name | Lannett Company, Inc. |
| Openfda › Application number | ANDA203899 |
| Openfda › Is original packager | true |
| Event id | 99107 |
| Address 1 | 1101 C Ave W |
| Code info | Lot #: 25282724A, Exp. Date 2027/01 |
| Postal code | 47274-3342 |
| Report date | 20260610 |
| Product type | Drugs |
| Product quantity | 3984 bottles |
| Reason for recall | Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260527 |
| Initial firm notification | Letter |
| Center classification date | 20260610 |
Overview
- Recalling FirmLannett Company Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States