Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Bionpharma Inc.

NDC code

69452-435-30

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0742-2026

Other Divalproex recalls

See all

Class II · Moderate risk Terminated Dec 26, 2023

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd…

Reason Failed dissolution specifications

Amneal Pharmaceuticals of New York, LLC NDC 65162-755-10 D-0426-2024

Class II · Moderate risk Terminated Jul 27, 2022

Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal…

Reason Failed dissolution specifications.

Amneal Pharmaceuticals of New York, LLC NDC 65162-755-10 D-1362-2022

Class II · Moderate risk Terminated Jun 27, 2022

Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc…

Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

Sun Pharmaceutical Industries INC NDC 62756-798-88 D-1291-2022

Class II · Moderate risk Terminated Apr 24, 2019

DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's…

Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Major Pharmaceuticals NDC 0904-6363-61 D-1583-2019

Class II · Moderate risk Terminated Apr 11, 2019

Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC…

Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Dr. Reddy's Laboratories, Inc. NDC 55111-0533-01 D-1133-2019