Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Niacin Extended-Release Tablets Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to CGMP Deviations: Microbial contamination was reported in stagnant...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SUN PHARMACEUTICAL INDUSTRIES INC directly.
Affected Products
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.
Quantity: 15,768 bottles
Why Was This Recalled?
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SUN PHARMACEUTICAL INDUSTRIES INC
SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report