NIACIN

Generic: NIACIN

Lupin PharmaceuticalsManufacturer
ORALRoute
NIACINActive Substance
2014-03-20Original Approval

NIACIN is FDA application ANDA090892, sponsored by CHARTWELL RX. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2025-10-10
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., P

Failed Dissolution Specifications

Class II2025-10-20
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceu

Failed Dissolution Specifications

Class II2024-01-18
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industrie

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu

Class II2024-01-18
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industri

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufactu

Class II2026-05-29
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Ph

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out

Class II2026-05-27
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philad

Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution a

Top Reported Reactions

1
FATIGUE
759 reports
2
DRUG INEFFECTIVE
742 reports
3
NAUSEA
676 reports
4
DIARRHOEA
642 reports
5
DIZZINESS
550 reports
6
DYSPNOEA
533 reports
7
DRUG HYPERSENSITIVITY
493 reports
8
PAIN
492 reports
9
HEADACHE
477 reports
10
ASTHENIA
445 reports