Prescription Niacin Tablets Recalled for Microbial Contamination
Sun Pharmaceutical is recalling Niacin Extended-Release Tablets nationwide due to microbial contamination found in manufacturing equipment. Affected lot numbers expire in June and July 2025.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with unspecified microbial contamination and no reported illnesses or injuries. Without identification of a named high-risk pathogen or evidence of harm, this meets criteria for Moderate severity.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Niacin Extended-Release Tablets, USP 500mg, due to microbial contamination discovered during manufacturing. Specifically, microbial contamination was found in stagnant water in equipment ducts, which violates Current Good Manufacturing Practices (CGMP).
The recall affects 15,768 bottles distributed nationwide in the United States. The affected lot numbers are: DNE0771A (expiration 06/30/2025), DNE0857A, and DNE0959A (expiration 07/31/2025). The product is a prescription-only medication.
Patients taking affected lots should consult their healthcare provider or pharmacist for guidance. Pharmacies should verify their inventory against the recalled lot numbers and quarantine any affected stock.
The recalled product
- Product
- NIACIN (NIACIN)
- Brand
- NIACIN
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Vitamin
- Hazard
- Affected units
- 15,768
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 (3)
- Lot #s: DNE0771A Exp. 06/30/2025
- DNE0857A
- DNE0959A 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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Similar recalls
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