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Dr. Reddy's Laboratories, Inc. Recall: Divalproex Sodium Extended-Release Tablets, USP, 25

Dr. Reddy's Laboratories, Inc. Recall: Divalproex Sodium Extended-Release Tablets, USP, 25 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Dr. Reddy's Laboratories, Inc.; Product: Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-co

Recalling firmDr. Reddy's Laboratories, Inc.
ProductDivalproex 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
Reason for recallcGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionProduct was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
Recall initiated20190411
Recall numberD-1133-2019
Categorydrug
StateNJ
CountryUnited States

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