Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Divalproex Sodium Extended-Release Tablets Recalled by Dr. Reddy's Laboratories, Inc. Due to cGMP deviations: Product was exposed above 50% relative...
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
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Quantity: 33,958 bottles
Why Was This Recalled?
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Where Was This Sold?
Product was distributed to major distributors and retailers who may have further distribute the product throughout the United 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