Niacin Extended-Release Tablets Recalled for Manufacturing Microbial Contamination
Sun Pharmaceutical recalls 6,552 bottles of Niacin Extended-Release Tablets (1000mg) nationwide due to microbial contamination in manufacturing equipment. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for Good Manufacturing Practice deviations involving unidentified microbial contamination in manufacturing equipment. Although no specific pathogen is identified and no illnesses have been reported, the contamination represents a material risk of harm consistent with the FDA's Class II serious-health-consequences classification.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 6,552 bottles of Niacin Extended-Release Tablets, USP 1000mg (Rx Only), distributed nationwide in the United States. The affected product is manufactured by Sun Pharmaceutical Industries Limited in India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey.
The U.S. Food and Drug Administration (FDA) classified this as a Class II recall after discovering Good Manufacturing Practice (CGMP) deviations at the manufacturing facility. Specifically, microbial contamination was identified in stagnant water within a duct of the manufacturing equipment used to produce these tablets.
The affected product can be identified by Lot #DNE0788A with an expiration date of 07/31/2025 and National Drug Code (NDC) 47335-613-81. The lot was distributed nationwide to pharmacies and other distributors. No illnesses or injuries related to this product have been reported as of the recall announcement.
The recalled product
- Product
- NIACIN (NIACIN)
- Brand
- NIACIN
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Oral Prescription
- Hazard
- Affected units
- 6,552
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: DNE0788A Exp. 07/31/2025
UPCs (3)
- 0347335613810
- 0347335614817
- 0347335539813
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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