Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dr. Reddy's Quetiapine Fumarate Tablets Recalled by Dr. Reddy's Laboratories, Inc. Due to Failed USP Dissolution Test Requirements: During analysis of...
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 Dr. Reddy's Laboratories, Inc. directly.
Affected Products
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Quantity: 1512 bottles
Why Was This Recalled?
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Laboratories, Inc. has 163 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report