Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Olanzapine Tablets Recalled by Sun Pharmaceutical Industries, Inc. Due to Failed Impurities/Degradation Specifications: out of specification results for...
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
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
Quantity: 14,784 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report